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Extra strength taminol acetaminophen - Medication Information

Product NDC Code 52524-0000
Drug Name

Extra strength taminol acetaminophen

Type Brand
Active Ingredients
Acetaminophen 500 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 198440
Application Number M013
Labeler Name VIVA PHARMACEUTICAL INC
Packages
Package NDC Code Description
52524-0000-1 200 tablet in 1 bottle (52524-0000-1)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Acetaminophen 500mg Purposes Pain reliever/Fever reducer

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 chiledren 12 years and over ■ take two caplets every 6 hour while symptoms last ■ do not take more than 8 caplets in 24hours unless directed by a doctor ■ do not take more than 10 days unless directed by a doctor Children under 12 years ■ ask a doctor
Adults and chiledren 12 years and over ■ take two caplets every 6 hour while symptoms last ■ do not take more than 8 caplets in 24hours unless directed by a doctor ■ do not take more than 10 days unless directed by a doctor
Children under 12 years ■ ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Crospovidone , microcrystalline cellulose , Stearic acid , Silicon dioxide

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 & pain 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.
Purposes Pain reliever/Fever reducer

Spl product data elements

Usually a list of ingredients in a drug product.
Extra Strength Taminol Acetaminophen ACETAMINOPHEN CROSPOVIDONE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE STEARIC ACID SILICON DIOXIDE ACETAMINOPHEN ACETAMINOPHEN

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.
Package Labeling: Label0

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts Active ingredient Acetaminophen 500mg Purposes Pain reliever/Fever reducer Other information ■ store at 20°-25°C (68°-77°F)

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have liver disease

Ask doctor or pharmacist

Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
Ask a doctor or pharmacist before use if you are taking blood thinner

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use ■with any other drug containg acetaminophen (prescription or non prescription).If you are not sure whether a drug contains acetmniophen.ask doctor or pharmacist. ■ if you are ailergic to acetaminophen or any inactive ingrident in this product.

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 (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.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if ■ pain get worse or last more than 10 days ■ fever gets worse or lasts more than 3 days condition ■ new sympton occurs ■ redness or swelling present

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnancy or breast-feeding , ask a healthcare professional before use.

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 conatins acetaminophen.Severe liver damage may occur if yo take ■ more than 4,000 mg of acetaminophen in 24hr ■ with other drug conating acetaminophen ■ 3 or more alcholic drinks everyday 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 containg acetaminophen (prescription or non prescription).If you are not sure whether a drug contains acetmniophen.ask doctor or pharmacist. ■ if you are ailergic to acetaminophen or any inactive ingrident in this product. Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking blood thinner Stop use and ask a doctor if ■ pain get worse or last more than 10 days ■ fever gets worse or lasts more than 3 days condition ■ new sympton occurs ■ redness or swelling present If pregnancy or breast-feeding , ask a healthcare professional before use. 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 do not notice any signs or symptoms.

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