Label: CAREALL ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet
- NDC Code(s): 51824-099-01, 51824-099-24
- Packager: New World Imports, Inc
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 16, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4000 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.
Do not use
- 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.
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.
Do not exceed recommended dosage.
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DOSAGE & ADMINISTRATION
Do not use more than directed (see overdose warnings)
Adults and children 12 years of age and older:
- Take 2 caplets every 6 hours while symptoms last.
- Do not take more than 6 caplets 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: consult 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:51824-099 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 OVAL (Oval) Size 18mm Flavor Imprint Code AZ;328 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-099-24 24 in 1 CASE 11/28/2023 1 NDC:51824-099-01 100 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 11/28/2023 Labeler - New World Imports, Inc (075372276)