Label: PAIN RELIEF MAXIMUM STRENGTH- acetaminophen,aspirin,caffeine tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 52904-468-02 - Packager: Select Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 15, 2012
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- ACTIVE INGREDIENT
- PURPOSE
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
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WARNINGS
Warnings: Reye's syndrome:
Children and teenagers should not use this medicine for chicken pox or
flu symptoms before a doctor is consulted about Reye's syndrome, a
rare but serious illness reported to be associated with aspirin. Allergy
Alert-Do not use: • if you are allergic to aspirin or any other salicylate •
If you have ever had an allergic reaction to any other pain
reliever/fever reducer Liver Warning: This product contains
acetaminophen. Severe liver damage may occur if you take: • more
than 8 tablets in 24 hours • with other drugs containing acetaminophen
(prescription or nonprescription). Ask a doctor or pharmacist before
using with other drugs if you are not sure. • 3 or more alcoholic drinks
every day while using this product Stomach Bleeding Warning: This
product contains nonsteroidal antiinflammatory dugs (NSAIDs), which
may cause 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 an
NSAID (aspirin, ibuprofen, naproxen, or others). • Take more or for a
longer time than directed Do not use: • if you are allergic to aspirin
• with any other pain reliever/fever reducer • if you have
ever had an allergic reaction to any other pain
reliever/fever reducer • for pain for more than 10 days or for
fever for more than 3 days unless directed by a doctor • with
any other product containing acetaminophen Ask doctor
before using if you have: • asthma • stomach problems (such as
heartburn, upset stomach or stomach pain) • gastric ulcers • bleeding
problems Ask a doctor or pharmacist before use if you are taking a
prescription 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 or
swelling is present - PREGNANCY OR BREAST FEEDING
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- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN RELIEF MAXIMUM STRENGTH
acetaminophen,aspirin,caffeine tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-468 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength POVIDONE K29/32 (UNII: 390RMW2PEQ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) MALTODEXTRIN (UNII: 7CVR7L4A2D) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (snow white) Score no score Shape ROUND (FR9) Size 12mm Flavor Imprint Code FR9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52904-468-02 2 in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 10/15/2012 Labeler - Select Corporation (053805599)