![EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG CONSORTIUM, LLC]](https://medic.hrt.org//dailymed/images/05e11584-1876-0207-e054-00144ff88e88/pv251.jpg)
| NDC | 68016-029-14, 68016-029-20, 68016-029-47 |
| Set ID | 05e11584-1876-0207-e054-00144ff88e88 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Chain Drug Consortium, LLC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART343 |
- Active ingredient
- Purpose
- Uses
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Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 gelcaps 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 more than 10 days
- fever gets worse or lasts more than 3 days
- new symptom occur
- redness or swelling is present
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Directions
- Other Information
- package label
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PAIN RELIEF
acetaminophen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-029 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C RED NO. 40 (UNII: WZB9127XOA) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSES (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) SHELLAC (UNII: 46N107B71O) Product Characteristics Color red (with blue and a gray band) Score no score Shape CAPSULE (Gelcap) Size 19mm Flavor Imprint Code L;5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-029-20 1 in 1 CARTON 09/01/2007 1 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:68016-029-14 1 in 1 CARTON 09/01/2007 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:68016-029-47 400 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 09/01/2007 Labeler - Chain Drug Consortium, LLC (101668460) Registrant - Geri-Care Pharmaceutical Corp (611196254) Establishment Name Address ID/FEI Business Operations Geri-Care Pharmaceutical Corp 611196254 repack(68016-029)
