Sign In

Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"

You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.

View Generic:
View Brand:

Acetaminophen pain reliever,fever reducer - Medication Information

Product NDC Code 68071-4118
Drug Name

Acetaminophen pain reliever,fever reducer

Type Brand
Active Ingredients
Acetaminophen 325 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 313782
Application Number part343
Labeler Name NuCare Pharmaceuticals,Inc.
Packages
Package NDC Code Description
68071-4118-2 20 tablet in 1 bottle (68071-4118-2)
68071-4118-3 30 tablet in 1 bottle (68071-4118-3)
68071-4118-4 40 tablet in 1 bottle (68071-4118-4)
68071-4118-5 25 tablet in 1 bottle (68071-4118-5)
68071-4118-6 60 tablet in 1 bottle (68071-4118-6)
Check if available Online

Overdosage of ACETAMINOPHEN Pain Reliever,Fever Reducer

Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each tablet) Acetaminophen 325 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 AGE DOSE Adults and Children 12 years and over Take 2 tablets every 4 to 6 hours while symptoms last Do not take more than 12 tablets in 24 hours Children 6 - 11 years Take 1 tablet every 4 to 6 hours while symptoms last Do not take more than 5 tablets in 24 hours Children under 6 years Do not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.
AGEDOSE
Adults and Children 12 years and overTake 2 tablets every 4 to 6 hours while symptoms lastDo not take more than 12 tablets in 24 hours
Children 6 - 11 yearsTake 1 tablet every 4 to 6 hours while symptoms last Do not take more than 5 tablets in 24 hours
Children under 6 yearsDo not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients 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 relief of minor aches and pains due to: Headache Muscular aches Backache Minor pain of arthritis The common cold Toothache 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.
ACETAMINOPHEN Pain Reliever,Fever Reducer ACETAMINOPHEN POVIDONE STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID ACETAMINOPHEN ACETAMINOPHEN round flat faced beveled edge GPI;A325

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.
Principal Display Panel PDP

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.
Other information Do not use if imprinted Safety Seal under cap is broken or missing Store at room temperature

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 the user has 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 the user is taking the blood thinning drug warfarin.

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 containing acetaminophen (prescription or non prescription). 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

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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

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 gets worse or lasts more than 10 days in adults and children Pain gets worse or lasts more than 5 days in children under 12 years Fever gets worse or lasts more than 3 days New symptoms occur Redness or swelling is present These could be signs of a serious condition.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding , ask a health 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 contains acetaminophen. Severe liver damage may occur if adult takes more than 12 tablets in 24 hours, which is the maximum daily amount 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 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 non prescription). 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 the user has liver disease. Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin. Stop use and ask a doctor if Pain gets worse or lasts more than 10 days in adults and children Pain gets worse or lasts more than 5 days in children under 12 years Fever gets worse or lasts 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. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose get medical help or contact a Poison Control Center right away. (1-800-222-1222). 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