FDA Label for Diphen

Other

REMEDY PACK

Burn Cream

Drug Facts

Triple Antibiotic

Drug Facts

Hydrocortisone Cream

Drug Facts

Oral Pain Relief Gel

Drug Facts

Do not exceed recommended dosage.

• If more than used for pain is accidently swallowed, get medical help or contact a Poison Control Center right away.

Alcalak

Drug Facts

Cold Relief

Drug Facts

Medi-Meclizine

Drug Facts

I-Prin

Drug Facts

Diphen

Drug Facts

Extra Strength APAP

Drug Facts

Loradamed

Drug Facts

Medi-Lyte

Drug Facts

Diotame

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.13%, Lidocaine HCl 0.5%

Benzocaine 20%

Diphenhydramine HCl 25mg

Purpose

Topical antiseptic, Topicall analgesic

Anti-Itch

Oral Anesthetic

Antacid

Antiemetic

Pain reliever/fever reducer

Antihistamine

Antihistamine

Pain reliever/fever reducer

Antihistamine

Upset stomach reliever/antidiarrheal

Uses

First aid to help prevent infection in minor cuts, scrapes and burns.

For the temporary relief of pain and itching associated with:

• sunburn
• insect bites
• cuts
• minor skin irritations
• scrapes
• minor burns

First aid to help prevent infection in:

• minor cuts
• scrapes
• burns
• eczema
• insect bites
• poison ivy
• Poison oak
• poison sumac
• Cosmetics
• jewelry
• soaps detergents
• seborrheic
• dermatitis
• Psoriasas

Other uses of this product should only be under the advice and supervision of a doctor.

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

For the relief of the following symptoms associated with

• acid indigestion
• sour stomach
• heartburn
• upset stomach

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

• cough
• sore throat
• minor aches and pains
• headache
• nasal congestion
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Temporarily reduces fever.

For the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.

For the reduction of fever.

Temporarily relieves minor aches and pains associated with

• headache
• toothache
• backache
• menstrual cramps
• common cold
• muscular aches
• minor arthritis pain

Temporarily reduces fever.

For the temporary relief of minor aches and pains associated with

• headache
• muscular aches
• minor arthritis pain
• common cold
• toothache
• menstrual cramps

For the reduction of fever.

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

• runny nose
• itchy, watery eyes
• sneezing
• itching of the nose or throat

Nutritional support for the following symptoms due to excessive loss of perspiration

• heat fatigue
• muscle cramps
• heat exhaustion
• heat stroke
• replaces lost electrolytes
• helps provide rapid rehydration

*This statement has not been evaluated by the Food and Drug administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Temporarily relieves

• travelers' diarrhea
• diarrhea
• upset stomach due to overindulgence in food and drink, including
  • -heartburn
  • -indigestion
  • -nausea
  • -gas
  • -belching
  • -fullness
  
  

Warning

For external use only.

• For external use only
• For external use only
• avoid contact with the eyes
• if condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor

Do Not Use

• in the eyes
• over large areas of the body or on deep puncture wounds, animal bites, or serious burns
• in large quantities, particularly over raw surfaces or blistered areas
• in the eyes
• over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor

For more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly.

• for teething
• in children under 2 years of age
• the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician, or take more than 19 tablets in a 24 hour period.
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you have ever had an allergic reaction to this product or any of the ingredients.
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• for children under 12 years of age unless directed by a doctor
• for frequent or prolonged use except under the advice of a doctor
• if you have ever had an allergic reaction to any other pain reliever/ fever reducer
• right before or after heart surgery
• to make a child sleepy
• with any other product containing diphenhydramine, even one that is used on skin
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor

Stop Use And Ask Doctor If

• the condition gets worse
• condition clears up and recurs within a few days
• condition persists for more than 7 days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a health care professional before use.

• If pregnant or breast feeding,ask a health care professional before use.

If pregnant or breastfeeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

• Keep out of reach of children.
• If swallowed, get medical help or consult a poison control center right away.
• Keep out of reach of children.

Keep out of reach of children.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center immediately.

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately.

Directions

Adults and children 2 years and over:

• clean the affected area
• apply a small amount of this product on the area 3 to 4 times daily
• may be covered with a sterile bandage
• Children under 12 years: consult a doctor
• Children under 2 years: consult a doctor

clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
may be covered with a sterile bandage

Adult and children (2 years and over): apply to affected not more than 3 to 4 times daily

Children under 2 years: Consult a doctor.

• Apply only amount needed to the oral mucosa to prevent or relieve pain.
• children under 2 years of age: do not use
• do not use more than directed

Adults and children: (12 years and older) Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a physician. Do not exceed 19 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

Adults and children: (12 years and older) Take 2 tablets with water every 6- 8 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

• do not use more than directed
• to prevent motion sickness, take the first dose one hour before starting activity

Adults and children: (12 years and older) 1 to 2 tablets once daily or as directed by a doctor. Do not exceed 2 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

• do not take more than directed
• the smallest effective dose should be used
• do not take longer than 10 days, unless directed by a doctor (see Warnings)

Adults and children: (12 years and older) Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

• do not use more than directed

Adults and children: (12 years and older) Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

• do not use more than directed

Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Adults and children: (12 years and older) Take 1 tablet daily; not more than 1 tablet in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

Consumers with liver or kidney disease: Ask a doctor before using.

Adults and children: (12 years and older)

• take 2 tablets as needed with a full glass of water
• may be repeated every hour as needed
• do not exceed 20 tablets in 24 hours

Children under 12 years:

• Do not give to children under 12 years of age
• do not use more than directed
• chew or crush tablets completely before swallowing
• do not swallow tablets whole
• use until diarrhea stops but not more than 2 days
• drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
• do not exceed 16 tablets in 24 hours

Adults and children: (12 years and older) Chew 2 tablets every 1/2 to 1 hour or 4 tablets every hour as needed.

Children under 12 years: Do not give to children under 12 years of age.

Other Information

• store in a cool, dry area 59° to 79°F (15° to 25°C)
• tamper evident sealed packets
• do not use any opened or torn packets
• store at room temperature 15°C to 30°C (59°F to 86°F) (do not freeze) tamper evident. Do not use if packet is torn, cut or opened.
• avoid excessive heat and humidity
• store at room temperature 59-86°F (15-30°C)
• do not freeze
• do not use any opened or torn packets.
• store at room temperature 15°C to 30°C (59°F to 86°F)
• protect from freezing
• Phenylketonurics: contains phenylalanine 1.5mg per tablet
• each tablet contains 168mg of elemental calcium
• store at room temperature 59°-86°F (15°-30°C) in a dry place
• tamper-evident sealed packets
• do not use any opened or torn packets
• store at room temperature 59°-86°F (15°-30°C)
• avoid excessive heat and humidity
• tamper-evident sealed packets
• do not use any opened or torn packets
• store at room temperature 59- 86° F (15-30°C)
• tamper-evident sealed packets
• do not use any opened or torn packets
• read all product information before using
• store at 68-77°F (20-25°C)
• avoid excessive heat 104°F (above 40°C)
• tamper-evident sealed packets
• do not use any opened or torn packets
• each caplet may contain: calcium 25mg
• protect from light
• use by expiration date on packet
• store at room temperature 59°-86°F (15°-30°C)
• tamper-evident sealed packets
• do not use any opened or torn packets
• store at room temperature 59°-86°F (15°-30°C)
• tamper-evident sealed packets
• do not use any opened or torn packets
• store at room temperature 68°-77°F (20°-25°C)
• protect from excessive moisture
• tamper-evident sealed packets
• do not use any opened or torn packets
• store at room temperature 59°-86° F (15°-30° C)
• avoid excessive heat and humidity
• tamper-evident sealed packets
• do not use any opened or torn packets
• no sodium added
• Phenylketonurics: contains phenylalanine 1.1mg per tablet
• each tablet contains 73mg of elemental calcium
• store at room temperature 59°-86°F (15°-30°C)
• tamper-evident sealed packets
• do not use any opened or torn packets

Inactive Ingredients

decolorized aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

mineral oil, white petrolatum

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white Wax.

Flavoring, PEG 3350, PEG 400, sodium sacchrin, water.

May contain blue #1, green #3, green #5 , red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as color additive.

Active Ingredient (In Each Gram)

Bacitracin zinc (400 units), Neomycin sulfate 5 mg (equivalent to 3.5 mg of Neomycin), Polymyxin-B sulfate 5000 units

Hydrocortisone 1.0%

Purposes

First aid antibiotics

Ask A Doctor Before Use

in case of deep or puncture wounds, animal bites, or serious burns

Stop Use And Ask A Doctor If

the condition persists or gets worse a rash or other allergic reaction develops

• symptoms last more than 2 weeks
• new symptoms occur
• redness or swelling is present
• pain or nasal congestion gets worse or lasts for more than 7 days
• fever gets worse or lasts for more than 3 days
• you get nervous, dizzy or sleepless
• cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

• you experience any of the following signs of stomach bleeding:
  • - feel faint
  • - vomit blood
  • - have bloody or black stools
  • - have stomach pain that does not get better
  • you have symptoms of heart problems or stroke
    • - chest pain
    • - trouble breathing
    • - weakness in one part or side of body
    • - slurred speech
    • - leg swelling
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • any new or unexpected symptoms occur
    • an allergic reaction to this product occurs. Seek medical help right away.
    • symptoms get worse
    • ringing in the ears or loss of hearing occurs
    • diarrhea lasts more than 2 days
    
    

Otc - Do Not Use

• do not use for the treatment of diaper rash.

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Methemoglobinemia Warning

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood.

This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

• pale, gray, or blue colored skin (cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

Allergy Alert

do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other " caine" anesthetics.

Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

• hives
• skin reddening
• facial swelling
• rash
• asthma (wheezing)
• blisters
• shock

If an allergic reaction occurs, stop use and seek medical help right away.

Acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Contains salicylate. Do not take if you are:

• allergic to salicylates (including aspirin)
• taking other salicylate products

When Using This Product

avoid contact with eyes. If it occurs, flush with water.

• do not use more than directed
• drowsiness may occur
• alcohol, sedatives and tranquilizers may increase the drowsiness effect
• avoid alcoholic beverages while taking this product
• use caution when driving a motor vehicle or operating machinery

Do not exceed recommended dosage.

• take with food or milk if stomach upset occurs
• marked drowsiness may occur
• avoid alcohol beverages
• alcohol, sedatives and tranquilizers may increase the drowsiness effect
• use caution when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Active Ingredient (In Each Tablet)

Calcium Carbonate 420mg

Meclizine Hydrochloride 25mg

Ibuprofen (NSAID

nonsteroidal anti-inflammatory drug

Diphenhydramine HCl 25mg

Acetaminophen 500mg

Loratadine 10mg

Bismuth Subsalicylate 262mg (each tablet contains 102mg salicylate)

Inactive Ingredientsmay Contain

aspartame, croscarmellose sodium, gum acacia, magnesium stearate, maltodextrin, mineral oil, mint flavor, sorbitol, sucrose

carnauba wax, corn starch, hypromellose, iron oxide red, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone (K-30), silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, titanium dioxide

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, titanium dioxide

corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Ask A Doctor Or Pharmacist Before Use If You Are

• presently taking a prescription drug. Antacids may interact with certain prescription drugs.
• taking the blood thinning drug warfarin
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• under a doctor's care for any serious condition
• taking any other drug
• taking sedatives or tranquilizers

Otc - Purpose

Inactive Ingredients*

maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

acacia gum, aspartame, calcium carbonate, D&C red #27, dextrates, flavoring, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4,000mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 8 tablets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Ask A Doctor Before Use If You Have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema
• breathing problems such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland if you are
• taking sedatives or tranquilizers
• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to enlargement of the prostate gland
• glaucoma
• liver disease
• fever
• mucus in the stool

Stomach Bleeding Warning

This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Heart attack or stroke warning: NSAIDS, except aspirin, increase the risk of heart attack, heart failure, and stroke.

These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Ask A Doctor Before Use If

• you have problems or serious side effects from taking pain relievers or fever reducers
• stomach bleeding warning applies to you
• you have a history of stomach problems such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke
• you are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If

• you are taking the blood thinning drug warfarin

Stop Using And Ask A Doctor If

• symptoms do not improve
• new symptoms occur
• pain or fever persists or gets worse
• redness or swelling is present

Otc - Ask Doctor

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Otc - When Using

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

When using this product a temporary and harmless darkening of the tongue and/or stool may occur. Stool darkening should not be confused with melena.

Information

Serving Size: 2 tablets

Servings Per Packet: 1

Other Ingredients

microcrystalline cellulose, silicon dioxide, stearic acid, magnesium stearate

Otc - Active Ingredient

Reye's Syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome a rare but serious illness.

Do Not Use If You Have

• bloody or black stool
• an ulcer
• a bleeding problem

Ask A Doctor Or Pharmacist If You Are Taking Any Drug For

• anticoagulation (thinning of the blood)
• diabetes
• gout
• arthritis

Principal Display Panel - Kit Carton

REMEDY PACK

DRUG FACTS

www.theremedypack.com

PRINCIPAL DISPLAY PANEL - Kit Carton - remedy 01