Label: ACETAMINOPHEN tablet
- NDC Code(s): 68788-8636-1, 68788-8636-2, 68788-8636-3, 68788-8636-5
- Packager: Preferrred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-6730
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 17, 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
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WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 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.
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- if you are allergic to acetaminophen or any of the inactive ingredients in this product
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Directions
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- 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?
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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®
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PRINCIPAL DISPLAY PANEL
MAJOR
THIS LARGE SIZE PACKAGE FOR DISPENSING PURPOSE ONLY
See New Warnings Information and Directions
Acetaminophen Extra Strength Tablets
Aspirin Free
Extra Strenght Pain reliever
Compare to active ingredient in Extra Strength Tylenol®* Tablets
500mg each
Relabeled By: Preferred Pharmaceuticals Inc.
NDC 68788-8636
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-8636(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:68788-8636-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 04/17/2024 2 NDC:68788-8636-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/17/2024 3 NDC:68788-8636-5 50 in 1 BOTTLE; Type 0: Not a Combination Product 04/17/2024 4 NDC:68788-8636-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/17/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 343 04/17/2024 Labeler - Preferrred Pharmaceuticals Inc. (791119022) Registrant - Preferrred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferrred Pharmaceuticals Inc. 791119022 REPACK(68788-8636)
