Label: QUALITY CHOICE EXTRA STRENGTH PAIN RELIEF- acetaminophen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 63868-978-08 - Packager: Chain Drug Marketing Association
- 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 August 23, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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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
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
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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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
QUALITY CHOICE EXTRA STRENGTH PAIN RELIEF
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-978 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 POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape OVAL Size 12mm Flavor Imprint Code PH044 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-978-08 1 in 1 CARTON 1 8 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 08/23/2014 Labeler - Chain Drug Marketing Association (011920774) Registrant - Reese Pharmaceutical Co (004172052) Establishment Name Address ID/FEI Business Operations Reese Pharmaceutical Co 004172052 relabel(63868-978) , repack(63868-978) Establishment Name Address ID/FEI Business Operations Pharbest 557054835 manufacture(63868-978)
