Label: ACETAMINOPHEN tablet
- NDC Code(s): 50090-5350-0, 50090-5350-1
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 0904-6730
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 27, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- Uses
-
WARNINGS
Liver warning: This product contains acetaminophen. 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
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.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
-
Directions
- do not take more than directed (see overdose warning)
adults and children 12 years and over:
• take 2 tablets every 6 hours while symptoms last
• do not take more than 6 tablets in 24 hours, unless directed by a doctor
• do not take for more than 10 days unless directed by a doctor
children under 12 years: ask a doctor
- Other Information
- INACTIVE INGREDIENT
- Questions or comments?
-
SPL UNCLASSIFIED SECTION
SAVE CARTON FOR COMPLETE DRUG FACTS
Do not use if carton is open or if imprinted safety seal under cap is broken or missing.
Distributed By:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®
- HOW SUPPLIED
- Acetaminophen
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-5350(NDC:0904-6730) 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 STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color white Score 2 pieces Shape ROUND Size 12mm Flavor Imprint Code 54;27 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-5350-0 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/10/2020 2 NDC:50090-5350-1 42 in 1 BOTTLE; Type 0: Not a Combination Product 12/08/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 09/12/2018 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-5350) , REPACK(50090-5350)
