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Product NDC Code | 51824-085 | ||||
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Drug Name | Careall acetaminophen |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | TABLET | ||||
RxCUI drug identifier | 313782 | ||||
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 Acetaminophen 325mg
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.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. Do not use 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 for more than 5 days unless directed by a doctor Children under 6 years of age: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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 Temporary relieves minor aches and pains due to: the common cold, headache, toothache, muscular aches, backache, minor pain of arthritis, premenstrual and menstrual cramps, and reduction of 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 Acetaminophen Acetaminophen Acetaminophen Starch, Corn Stearic Acid Povidone SODIUM STARCH GLYCOLATE TYPE A CORN white Round Circle M2A3;57344
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.ACT32524
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 immediately (1-800-222-1222). Quick medical attention is critical for adults as well as for chidren 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: 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 or any of the inactive ingredients in this product. 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. Stop use and ask a doctor if: Pain gets worse or lasts for more than 10 days. Pain gets worse or lasts more than 5 days in children under 12 years. 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 or 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