Label: EXTRA STRENGTH ACETAMINOPHEN- acetaminophen tablet
- NDC Code(s): 57896-222-01, 57896-222-10, 57896-222-20
- Packager: Geri-Care Pharmaceutical Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 19, 2023
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- Active ingredient
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Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:- more than 8 caplets (4,000 mg of acetaminophen) in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include:- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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 aretaking 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.
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-222 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 (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white (WHITE) Score no score Shape CAPSULE (Capsule) Size 17mm Flavor Imprint Code AZ328 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-222-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2018 2 NDC:57896-222-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2018 3 NDC:57896-222-20 200 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 08/01/2018 Labeler - Geri-Care Pharmaceutical Corp (611196254) Registrant - Geri-Care Pharmaceutical Corp (611196254)
