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Product NDC Code | 51824-060 | ||||
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Drug Name | Careall acetaminophen extra strength |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | TABLET | ||||
RxCUI drug identifier | 198440 | ||||
Application Number | M013 | ||||
Labeler Name | New World Imports, Inc | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Acteminophen 500 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Do not use more than directed (see overdose warning) Adults and children 12 years of age and older : Take 2 tablets every 6 hours as needed. 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 of age: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For the temporary of minor aches and pains associated with: common cold, headache, toothache, muscular aches, backache, arthritis, premenstrual and menstrual cramps Temporarily reduces fever.
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever / Fever reducer
Spl product data elements
Usually a list of ingredients in a drug product.CareALL Acetaminophen Extra Strength Acetaminophen Acetaminophen Acetaminophen Starch, Corn Stearic Acid Povidone Sodium starch glycolate Type A potato White round AZ;011
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.APAP label
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of Children Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you don't notice any signs or symptoms.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 -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: -Symptoms do not improve -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 -A rare sensitivity reaction occurs If pregnant of breast-feeding, ask a health professional before use.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API