![QUALITY CHOICE EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]](https://medic.hrt.org//dailymed/images/7198fefd-b95b-4c8e-b70a-5ea061098baa/carton.jpg)
| NDC | 63868-978-08 |
| Set ID | 7198fefd-b95b-4c8e-b70a-5ea061098baa |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Chain Drug Marketing Association |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART343 |
- 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
-
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)
