- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
-
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
■ more than 8 caplets 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 lasts more than 10 days or gets worse
■ redness or swelling is present in the painful area
■ any new symptoms appear - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
INACTIVE INGREDIENT
Inactive ingredients
croscarmellose sodium, crospovidone, FDC red 40 aluminum lake, hydroxypropyl methylcellulose, maltodextrin*, magnesium
stearate*, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, povidone, sodium starch glycolate*, starch, stearic acid,
titanium dioxide
*contains one or more of these ingredients - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN AID PMF
acetaminophen, pamabrom tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35418-710 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM 25 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 2S7830E561) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE K29/32 (UNII: 390RMW2PEQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color pink (rose pink) Score no score Shape CAPSULE (ZEE;PM) Size 18mm Flavor Imprint Code ZEE;PM Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35418-710-68 50 in 1 CARTON 06/12/2012 1 NDC:35418-710-67 125 in 1 CARTON 1 NDC:35418-710-02 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 06/12/2012 Labeler - Zee Medical Inc (009645623) Registrant - Ultra Seal Corporation (085752004) Establishment Name Address ID/FEI Business Operations Ultratab Laboratories, Inc. 151051757 manufacture(35418-710) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 repack(35418-710)