Label: REGULAR STRENGTH PAIN RELIEF- acetaminophen tablet
- NDC Code(s): 60760-453-50
- Packager: St. Mary's Medical Park Pharmacy
- This is a repackaged label.
- Source NDC Code(s): 57896-102
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 12, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen.
The maximum daily dose of this product is 10 tablets
in 24 hours. Severe liver damage may occur if you take:- more than 12 tablets (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 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. - Directions
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
REGULAR STRENGTH PAIN RELIEF
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60760-453(NDC:57896-102) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code GC101 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60760-453-50 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2021 01/31/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 03/15/2021 01/31/2023 Labeler - St. Mary's Medical Park Pharmacy (063050751) Establishment Name Address ID/FEI Business Operations St. Mary's Medical Park Pharmacy 063050751 relabel(60760-453) , repack(60760-453)
