FDA Label for Mountain Series Weekender Medical
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - STOP USE
- OTC - DO NOT USE
- DIRECTIONS
- INACTIVE INGREDIENTS
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- ACTIVE INGREDIENTS
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT (IN EACH TABLET)
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- ADULTS AND CHILDREN: (12 YEARS AND OLDER)
- CHILDREN UNDER 12 YEARS:
- OTHER INFORMATION
- QUESTIONS OR COMMENTS?
- 116R MEDIQUE APAP 325 MG LABEL
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- 182R MEDIQUE DIPHEN LABEL
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- DOSAGE & ADMINISTRATION
- OTC - QUESTIONS
- PRINCIPAL DISPLAY PANEL
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- STOP USING AND ASK A DOCTOR IF
- 145R MEDIQUE APAP 325 MG LABEL
- WEEKENDER KIT LABEL
- WARNINGS AND PRECAUTIONS
Mountain Series Weekender Medical Product Label
The following document was submitted to the FDA by the labeler of this product Tender Corporation Dba Adventure Medical Kits. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Active Ingredient:
Benzalkonium Chloride 0.40%
Purpose
Antiseptic
Triple Antibiotic
Pain reliever/fever reducer
Antihistamine
Pain reliever/fever reducer
Use
For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.
Warnings
Warning: For external use only.
For external use only.
Warnings
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 ingested, 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 the reach of children. In case of overdose, contact a physician or poison control center immediately.
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 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.
Otc - Stop Use
Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.
Stop use and consult a doctor:
if the condition persists or gets worse; a rash or other allergic reaction develops
Stop use and ask a doctor if
- 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
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- redness or swelling is present in the painful area
- any new or unexpected symptoms occur
Otc - Do Not Use
Do not use in the eyes or over large areas of the body.
Do not use: in eyes; over large areas of the body;
If allergic to any of the ingredients; for more than one week unless directed by a physician.
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Directions
Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.
Directions: clean affected area; apply 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
- 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) - drink a full glass of water with each dose
- do not use more than directed
- do not use more than directed
Inactive Ingredients
Inactive Ingredient: Purified water
croscarmellose sodium*, hypromellose, microcrystalline cellulose*, mineral oil*, polyethylene glycol*, propylene glycol*, starch, titanium dioxide*
*may contain
D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin, starch
corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone, pregelatinized starch*, sodium starch glycolate, stearic acid
* may contain
Other
LOT/EXP: Made in CHINA
20130301
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.
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 alcohol drinks every day while
using this product - take more or for a longer time than directed
- hives
- asthma (wheezing)
- rash
- blisters
- skin reddening
- facial swelling
- shock
- 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
- read all product information before using
- store at 68-77°F (20-25°C)
- avoid excessive heat 40°C (above 104°F)
- tamper evident sealed packets
- do not use any opened or torn packets
- more than 12 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
Adults and children: (12 years and older): Take 1 to 2 capsules every 4 to 6 hours as needed. Do not take more than 12 capsules in 24 hours.
Children under 12 years: Do not give to children under 12 years of age.
Allergy alert: Ibuprofen may cause a severe allergic reaction which may include:
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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.
Other information
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Package Label.Principal Display Panel
Antiseptic Towelette
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
1/pouch
GENUINE FIRST AID
Genuine Triple Antibiotic
First Aid Ointment
To Help Prevent Infection
Each Gram Contains:
Bacitracin Zinc 400 units
Neomycin Sulfate 5 mg
(equivalent to 3.5 mg
Neomycin base)
Polymyxin B Sulfate 5000 units
Net Wt. 0.5g ; (1/64 oz)
Manufactured in CHINA for
GENUINE FIRST AID.
Triple Antibiotic Ointment 10pcs
Net wt. 0.9g (1/32oz)
100
Triple Antibiotic
Active Ingredients
Active Ingredient: .........Bacitracin Zinc 400 units
Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)
Polymyxin B Sulfate 5000 units
(in each capsule)
Diphenhydramine Hydrochloride 25 mg
Indications & Usage
Uses: To help prevent infection in:
minor cuts; scrapes; burns
Uses
Temporarily relieves minor aches and pains associated with
■ headache■ backache■ common cold■ minor arthritis pain■ toothache■ menstrual cramps■ muscular aches
Temporarily reduces fever.
Storage And Handling
Other information:
Store at room temperature.
Inactive Ingredient
Water
Inactive ingredients
carnauba wax*, cellulose*, colloidal silicon dioxide, corn starch*, hypromellose, iron oxide red*, lactose, magnesium stearate, microcrystalline cellulose*, polydextrose, polyethylene glycol, povidone, silica*, sodium lauryl sulfate*, sodium starch glycolate, stearic acid*, titanium dioxide, triacetin*
*may contain
Active Ingredient (In Each Tablet)
Aspirin (NSAID*) 325 mg
*nonsteroidal anti-inflammatory drug
Acetaminophen 325 mg
Uses
Temporarily relieves minor aches and pains associated with
- headache
- minor arthritis
- common cold
- menstrual cramps
- muscular aches
- backache
- toothache
- headache
- common cold
- muscular aches
- toothache
- minor arthritis pain
- menstrual cramps
Temporarily reduces fever.
Temporarily relieves runny nose and decreases sneezing, itching of the nose and throat, itchy-watery eyes due to hay fever or other respiratory allergies.
For the temporary relief of minor aches and pains associated with
For the reduction of fever.
Do Not Use
- if you have ever had an allergic reaction to any other pain reliever/ fever reducer
- right before or after heart surgery
- if you are taking prescription drugs for gout, diabetes or arthritis
- 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
Ask A Doctor Before Use If
- 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
Ask A Doctor Or Pharmacist Before Use If You Are
- under a doctor's care for any serious condition
- taking any other drug
- taking any drugs for asthma
- taking sedatives or tranquilizers
When Using This Product
- 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
Stop Use And Ask A Doctor If
- 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
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- you have difficulty swallowing
- if ringing in the ears or loss of hearing occurs redness or swelling is present in the painful area
- any new symptoms appear
Otc - Pregnancy Or Breast Feeding
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 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. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to 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.
Adults And Children: (12 Years And Older)
Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.
Take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours.
Children Under 12 Years:
Do not give to children under 12 years of age.
Do not give to children under 12 years of age.
Other Information
- read all product information before using
- 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
- store at room temperature 59°-86°F (15°-30°C)
- tamper-evident sealed packets
- do not use any opened or torn packets
Questions Or Comments?
1-800-634-7680
116R Medique Apap 325 Mg Label
Medique®
Aspirin
5 Grain (325 mg)
Pain Reliever/Fever Reducer (NSAID)
See new warnings information
East To Swallow
Film Coated Tablets
24 Tablets
(12 x 2)
Compare active ingredients to Bayer®
Registered Trademark Bayer Consumer
Tamper Evident Unit Dose Packets
Ask A Doctor Before Use If You Have
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- glaucoma
- liver disease
182R Medique Diphen Label
Collect Medi-Bucks
See inside flap for more details
Medique®
Diphen
Diphenhydramine HCl 25 mg
Hay Fever/Allergies
Fiebre del Heno/Alergias
Pull to Open
TiraParaAbrir
Easy To Swallow Capsules
Capsulas Faciles de Tragar
200 Capsules
(200 x 1)
Tamper Evident Unit Dose Packets
Empaquetado con Sellado Evidente en Dosis Untarias
Otc - Active Ingredient
Active ingredient
(in each tablet)
Ibuprofen (NSAID*) 200 mg
*nonsteroidal anti-inflammatory drug
Povidone-iodine 10%
Otc - Purpose
Purpose
Pain reliever/fever reducer
Antiseptic
Otc - Ask Doctor
Ask a doctor before use if
- 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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- taking any other drug
Otc - When Using
When using this product
- take with food or milk if stomach upset occurs
Dosage & Administration
Directions
- do not use more than directed
- the smallest effective dose should be used
- do not take longer than 10 days, unless directed by a doctor (see Warnings)
Otc - Questions
Questions or comments? 1-800-634-7680
Principal Display Panel
Medi-First®
Ibuprofen 200 mg
Pain Reliever/Fever Reducer (NSAID)
Easy To Swallow Film Coated Tablets
See new warnings information
100 tablets (50 x 2)
Compare active ingredient to: Genuine Advil®
Registered trademark Wyeth Consumer
Tamper Evident Unit Dose Packets
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
145R Medique Apap 325 Mg Label
Collect MediBucks
See inside flap for more details
Medique®
APAP
Acetaminophen 325 mg
Pain Reliever/Fever Reducer
Alivia el Dolor/Reduce la Fiebre
Easy To Swallow
Film Coated Tablets
Facil de Tragar Tabletas con Cubierta Pelicular
Pull to Open
Tire Para Abrir
See new warnings information
500 Tablets
(250 x 2)
Tamper Evident Unit Dose Packets
Empaquetado con Sellado Evidente en Dosis Unitarias
Weekender Kit Label
Mountain Series Medical Kit Weekender
Adventure Medical Kits BE SAFE
1-6 People up to 7 days
Warnings And Precautions
Warnings
Do not use
- if allergic to iodine
- in the eyes
- deep or puncture wounds
- serious burns
- redness, irritation, swelling or pain persists or increases
- infection occurs
For external use only
Ask a doctor before use if injuries are
Stop use and ask a doctor if
Avoid pooling beneath patient
Keep out of reach of children. In case of accidental ingestion, seek professionalassistance or consult a poison control center immediately.
* Please review the disclaimer below.