FDA Label for Pain Relief Maximum Strength
View Indications, Usage & Precautions
Pain Relief Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Select Corporation. 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.
Otc - Active Ingredient
Active Ingredients
Acetaminophen 250 mgAspirin 250 mg
Caffeine 65 mg
Otc - Purpose
Pain Reliever, Fever Reducer
Dosage & Administration
Directions: Adults and children 12 years of age and older: 2 tablets as
needed for pain every 6 hours. Do not exceed 8 tablets in 24 hours or as
directed by a doctor. Children under 12 years: Consult a doctor
Indications & Usage
Uses: temporarily relieves minor aches and pains associated with:
• backache • headaches • colds • toothache • minor arthritis pain
• muscular aches
Warnings
Warnings: Reye's syndrome:Children and teenagers should not use this medicine for chicken pox orflu symptoms before a doctor is consulted about Reye's syndrome, arare but serious illness reported to be associated with aspirin. AllergyAlert-Do not use: • if you are allergic to aspirin or any other salicylate •If you have ever had an allergic reaction to any other painreliever/fever reducer Liver Warning: This product containsacetaminophen. Severe liver damage may occur if you take: • morethan 8 tablets in 24 hours • with other drugs containing acetaminophen(prescription or nonprescription). Ask a doctor or pharmacist beforeusing with other drugs if you are not sure. • 3 or more alcoholic drinksevery day while using this product Stomach Bleeding Warning: Thisproduct contains nonsteroidal antiinflammatory dugs (NSAIDs), whichmay cause stomach bleeding. The chance is higher if you: • are age 60or older • have had stomach ulcers or bleeding problems • take a bloodthinning (anticoagulant) or steroid drug • take other drugs containing anNSAID (aspirin, ibuprofen, naproxen, or others). • Take more or for alonger time than directed Do not use: • if you are allergic to aspirin• with any other pain reliever/fever reducer • if you haveever had an allergic reaction to any other painreliever/fever reducer • for pain for more than 10 days or forfever for more than 3 days unless directed by a doctor • withany other product containing acetaminophen Ask doctorbefore using if you have: • asthma • stomach problems (such asheartburn, upset stomach or stomach pain) • gastric ulcers • bleedingproblems Ask a doctor or pharmacist before use if you are taking aprescription drug for: • anticoagulation (thinning of blood) • diabetes •gout • arthritis. When using this product do not exceed recommended dose.Stop use and ask a doctor if: • ringing in the ears or loss of hearing occurs• pain or fever persists or gets worse • new symptoms occur • redness orswelling is present
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding baby, ask a health
professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE
ASPIRIN 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.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Inactive Ingredient
IInactive Ingredients: Hydroxypropyl Methylcellulose, Maltodextrin,
Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Starch
Glycolate, Starch, Stearic Acid, Titanium Dioxide
Package Label.Principal Display Panel
MM1
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