NDC | 57896-251-01 |
Set ID | e65dbd01-2d5e-4067-ad98-98d879cfb5ee |
Category | HUMAN OTC DRUG LABEL |
Packager | Geri-Care Pharmaceutical Corp |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- Active ingredient (in each gelcap)
- 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.
Keep out of reach of children
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
- Inactive Ingredients
- Package label
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PAIN RELIEF
acetaminophen capsule, gelatin coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-251 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) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color red (red, gray and blue) Score no score Shape CAPSULE (Gelcap) Size 19mm Flavor Imprint Code L5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-251-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 06/01/2007 Labeler - Geri-Care Pharmaceutical Corp (611196254) Registrant - Geri-Care Pharmaceutical Corp (611196254)