FDA Label for Quality Choice Extra Strength Pain Relief
View Indications, Usage & Precautions
Quality Choice Extra Strength Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association. 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
Acetaminophen
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- headache
- backache
- toothache
- the common cold
- minor pain of arthritis
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dosse of this product is 6 caplets (3,000 mg) in 24 hours. 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
Otc - Ask Doctor
Ask a doctor before use if you have
liver disease.
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
Otc - Stop Use
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
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 the recommended dose (overdose) may cause liver damamge. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions
- do not take more than directed (see overdose warning)
- adults and children 12 years and over
- take 2 caplets every 4 to 6 hours while symptoms last
- do not take more than 8 caplets in 24 hours
- do not take for more than 10 days unless directed by a doctor
- children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage
Other Information
- store 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredient
Inactive Ingredients
Polyvinylpyrrolidone, pregelatinized starch, sodium starch glycolate, stearic acid
Package Label.Principal Display Panel
* Please review the disclaimer below.