FDA Label for Only For Body Pain

Only For Headache- Acetaminophen, Aspirin, Caffeine Tablet

Drug Facts

Active Ingredient (In Each Geltab)

Acetaminophen 250mg

Aspirin 250mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever

Pain reliever aid

Antihistamine

Pain reliever

Nighttime sleep aid

Pain reliever / Fever reducer

Uses:

Temporarily relieves minor aches and pains due to:

• headache • a cold • arthritis • muscular aches • toothache • premenstrual & menstrual cramps

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
   • runny nose
   • sneezing
   • itchy, watery eyes
   • itching of the nose or throat

• temporarily relieves these symptoms due to the common cold:
   • runny nose
   • sneezing

• temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

• temporary relief minor aches and pains due to:

   • the common cold

   • backache

   • toothache

   • premenstrual and menstrual cramps

   • temporarily reduces fever.

   • headache

   • minor pain of arthritis

   • muscular aches

   • premenstrual and menstrual cramps

• temporarily reduces fever.

Warnings:

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flue-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.

Allergy alert: 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.

Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • asthma (wheezing) • shock

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 geltabs 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

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, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed

Caffeine warning: The recommended dose of this product contains about a much caffeine as cup of coffee. Limit the use of caffeine-containing medications, foods or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heart beat.

Do not use • if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if • you have liver disease • 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, or kidney disease • you are taking a diuretic • you have asthma

Ask a doctor or pharmacist before use if you are taking

• a prescription drug for diabetes, gout, or arthritis

• any other drug, or are under a doctor's care for any serious condition

Stop use and ask a doctor if • an allergic reaction occurs. Seek medical help right away. • 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 • ringing in the ears or loss of hearing occurs • painful area is red or swollen • pain gets worse or lasts for more than 10 days • fever gets worse or lasts for more than 3 days • any new symptoms occur

These could be signs of a serious condition

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

Do not use
• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin.

Ask a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are 

taking sedatives or tranquilizers

When using this product
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children.

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

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

• more than 4,000 mg of acetaminophen in 24 hours

• with other drugs containing acetaminophen

• 3 or more alcoholic drinks every day while using this product

Allergy Alert:

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.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

• with any other product containing diphenhydramine, even one used on skin

• in children under 12 years of age

• if you have ever had any allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

• liver disease

• a breathing problem such as emphysema or chronic bronchitis

• trouble urinating due to an enlarged prostate gland

• glaucoma.

Ask a doctor or pharmacist before use if

• you are taking the blood thinning drug warfarin

• taking sedatives or tranquilizers.

When using this product

• drowsiness will occur

• avoid alcoholic drinks

• do not drive a motor vehicle or operate machinery.

Stop use and ask a doctor if

• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

• pain gets worse or lasts more than 10 days

• fever gets worse or last more than 3 days

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

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

• more than 4,000 mg of acetaminophen in 24 hours

• with other drugs containing acetaminophen

• 3 or more alcoholic drinks every day while using this product

Allergy Alert:

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.

Do not use

• 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 any allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if are taking the blood thinning drug warfarin

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days

• fever gets worse or last more than 3 days

• new symptoms occur.

• redness or swelling is present

These could be signs of a serious condition.

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

OVERDOSE WARNING: Taking more than directed can cause serious health problems. In case overdose. get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

OVERDOSE WARNINGS: 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. OVERDOSE WARNINGS: 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.

Directions:

• do not use more than directed

• drink a full glass of water with each dose

• adults and children 12 years and over: take 2 geltabs every 6 hours; not more than 8 geltabs in 24 hours

• children under 12 years: ask a doctor

• take every 4 to 6 hours, or as directed by doctor

• do not take more than 6 doses in 24 hours

• take with a full glass of water

• Do not take more than directed. SEE OVERDOSE WARNING.

• do not take more than 2 caplets in 24 hours

Do not take more than directed. SEE OVERDOSE WARNING.

Other Information:

• store at room temperature between 20-25°C (68 to 77°F) • avoid excessive heat, cold and humidity • close cap tightly after use • read all product information before using.           

• store between 20-25°C (68-77°F) excursions permitted between 15-30°C (59-86°F).
• avoid excessive heat and light.
• store in dry place.           

• Store at room temperature between 20-25°C (68-77°F).

• avoid excessive heat, cold and humidity.

• close cap tightly after use.

• Store at room temperature between 20-25°C (68-77°F).

• avoid excessive heat, cold and humidity.

• close cap tightly after use.

Inactive Ingredients:

ammonium hydroxide, black iron oxide, brilliant blue FCF, corn starch, D&C yellow No.10 lake, ethyl cellulose, FD&C blue No.1 lake, FD&C red No.40 lake, gelatin, glycerin, hydroxypropyl methyl cellulose, isopropyl alcohol, isopropyl alcohol - butyl alcohol, lactose monohydrate, light liquid paraffin, microcrystalline cellulose, polysorb 85/70/00, povidone K30, pregelatinised starch, propylene glycol, purified water, shellac glaze, stearic acid, talc, titanium dioxide, triacetin

croscarmellose sodium, dicalcium phosphate, D&C red No.27 aluminium lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

colloidal silicon dioxide, croscarmellose sodium, FD&C blue No.1, hydroxy propyl methyl cellulose, magnesium stearate, starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide.

hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-833-665-9444. (Mon-Fri 9am-5pm)             

1-833-665-9444.
(Mon-Fri 9am - 5pm)           

1-833-665-9444. (Mon-Fri 9am-5pm)

1-833-665-9444. (Mon-Fri 9am-5pm)

Only For Allergy- Diphenhydramine Hcl Tablet

Drug Facts

Active Ingredient (In Each Caplet)

Diphenhydramine HCl 25mg

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Acetaminophen 500mg

Other

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

Only For Body Pain- Acetaminophen, Diphenhydramine Hcl Tablet

Drug Facts

Only For Fever- Acetaminophen Tablet

Drug Facts

Packaging

IMAGE - 73006132148