Label: CAREALL ACETAMINOPHEN- acetaminophen tablet
- NDC Code(s): 51824-085-01
- Packager: New World Imports, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 30, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Keep out of Reach of Children
- Uses
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WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
Adult takes more than 4,000mg of acetaminphen in 24 hours
Child takes more than 5 doses in 24 hours
Taken with other drugs containing acetaminophen
Adult has 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 or 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 allergic to acetaminophen or any of the inactive ingredients in this product.
Ask a doctor before use if user has: liver disease
Ask a doctor or pharmacist before use if:the user is taking the blood thinnig drug warfarin.
Stop use and ask a doctor if:
Pain gets worse or lasts for more than 10 days.
Pain gets worse or lasts more than 5 days in children under 12 years.
Fever gets worse or lasts for more than 3 days.
New symptoms 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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DOSAGE & ADMINISTRATION
Adults and children 12 years of age and older:
Take 2 tablets every 4 to 6 hours while symptoms last
Do not take more than 10 tablets in 24 hours.
Do not use for more than 10 days unless directed by a doctor
Children 6-11 years of age:
Take 1 tablet every 4 to 6 hours while symptoms last.
Do not take more than 5 tablets in 24 hours.
Do not use for more than 5 days unless directed by a doctor
Children under 6 years of age: Ask a doctor
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CAREALL ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-085 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 Starch, Corn (UNII: O8232NY3SJ) Stearic Acid (UNII: 4ELV7Z65AP) Povidone (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color white (white ) Score 2 pieces Shape ROUND (Round Circle) Size 10mm Flavor Imprint Code M2A3;57344 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-085-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/18/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 03/18/2021 Labeler - New World Imports, Inc (075372276)