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Product NDC Code | 51824-099 | ||||
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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.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 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
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.For the temporary relief of minor aches and pains associated with: the common cold, headache, toothache, muscular aches, backache, minor pain from arthritis, premenstural and menstrual cramps Temporarily reduces fever
Purpose
Information about the drug product’s indications for use.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 CORN White Oval AZ;328
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.50024ACC 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.In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not 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.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.
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