Label: CAREALL ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet
- NDC Code(s): 51824-086-01
- 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 you take:
-Adults take more than 4,000mg 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:
-If you are allergic to Acetaminophen or any of the inactive ingredients in this product.
-With other products 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 for more than 10 days
-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 of breast-feeding, ask a health professional before use.
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DOSAGE & ADMINISTRATION
Do not take more than directed (see overdose warning)
Adults and children 12 years of age and older:
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 use more than 10 days unless directed by a doctor
Children under 12 years of age: ask a doctor
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CAREALL ACETAMINOPHEN EXTRA STRENGTH
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-086 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 (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color white (White) Score no score Shape ROUND (round) Size 12mm Flavor Imprint Code M2A4;57344 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-086-01 100 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)
