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Product NDC Code | 11673-838 | ||||||||||
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Drug Name | Acetaminophen |
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Type | Generic | ||||||||||
Active Ingredients |
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Route | ORAL | ||||||||||
Dosage Form | TABLET, COATED | ||||||||||
RxCUI drug identifier | 198440 | ||||||||||
Application Number | part343 | ||||||||||
Labeler Name | TARGET CORPORATION | ||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (in each tablet) acetaminophen 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.Directions: Do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 caplets every 4 to 6 hours while symptoms last do not take more than 8 caplets in 24 hours do not take for more than 10 days unless directed by a doctor children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended does (overdose) of acetaminophen any may cause lier damage.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate* stearic acid, titanium dioxide *may contain this ingredient
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: temporarily relieves minor aches and pains due to: the common cold, headache, backache, minor pain of arthritis, toothache, muscular aches, premenstrual 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.acetaminophen acetaminophen MINERAL OIL STARCH, CORN ACETAMINOPHEN ACETAMINOPHEN HYPROMELLOSES POVIDONE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TITANIUM DIOXIDE TCL341
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.50 CT
100CT
225 CT
500 CT
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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt 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 4,000 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.
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