Label: PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 52904-446-02 - 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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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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DOSAGE & ADMINISTRATION
Directions: Adults and children
12 years of age and older: • take 2 tablets every 4 to 6 hours
as needed • do not take more than 8 tablets in 24 hours. Children
under 12 years of age: • do not use this extra strength product; this
will provide more than the recommended dose (overdose) and
could cause serious health problems.
- INDICATIONS & USAGE
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WARNINGS
Warnings:
Liver warning: This product contains acetaminophen. Severe
liver damage may occur if you take • more than 8 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 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. 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. Stop use and ask a
doctor if: • pain gets worse or lasts for more than 10 days • a
rare sensitivity reaction occurs • fever gets worse or lasts more
than 3 days • symptoms do not improve • new symptoms occur •
redness or swelling is present. You may report side effects to
888-952-0050. - PREGNANCY OR BREAST FEEDING
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- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PAIN RELIEF EXTRA STRENGTH
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-446 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) POVIDONE K29/32 (UNII: 390RMW2PEQ) Product Characteristics Color white (snow white) Score no score Shape ROUND (AZ235) Size 12mm Flavor Imprint Code AZ235 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52904-446-02 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) Registrant - Select Corporation (053805599)
