Label: CAREALL ACETAMINOPHEN- acetaminophen tablet
- NDC Code(s): 51824-061-01, 51824-061-02
- Packager: New World Imports, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 30, 2023
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- 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. The manxium daily dose of this product is 10 tablets (3,250 mg) in 24 hours fro adults or 5 tablets (1,625 mg) in 24 hours for children.
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.
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.
- is a child with pain of arthritis
Stop use and ask a doctor if:
- Adults pain gets worse or lasts for more than 10 days.
- Childs pain gets worse or last fr more than 5 days.
- Fever gets worse or lasts for more than 3 days.
- New symptoms occur.
- Redness or swelling is present.
If pregnant or breast-feeding,ask a health professional before use.
Overdose warning: taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical action is critical for adults as well as for children, even if you do not notice any signs or symptoms.
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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, unless directed by a doctor. do not take 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 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:51824-061 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 no score Shape ROUND (Round Circle) Size 11mm Flavor Imprint Code AZ;010 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-061-02 24 in 1 CASE 04/15/2016 1 NDC:51824-061-01 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 04/15/2016 Labeler - New World Imports, Inc (075372276)