Safetynadol Tablet, Coated
FDA Label NDC 81389-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sinew Pharma Inc. for the product Safetynadol (NDC 81389-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, activeingredient(ineachtablet), purpose, uses, warnings, do not use, ask a doctor before use, ask a doctor or a pharmacist before use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Activeingredient(Ineachtablet)

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

Uses

￭Temporarily relieves minor aches and pains due to:
￭the common cold ￭headache ￭backache ￭minor pain of arthritis ￭muscular aches ￭toothache ￭premenstrual and menstrual cramps ￭Temporarily reduces feverr

Warnings

Liver warning: This products 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 alcohol 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 captaining acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
￭if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use

if you have liver disease

Ask A Doctor Or A Pharmacist Before Use

if you are taking blood thinning drug warfarin

Stop Use And Ask A Doctor If

￭pain gets worse or last more than 10 days ￭new symptoms occur ￭fever gets worse or lasts more than 3 days ￭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:

In case of over dose, 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.

Directions

￭do not take more than directed (see overdose warning)

 Adults and children 12 years and over ￭take 2 tablets every 6 hours while symptoms last
￭do not take more than 6 tablets in 24 hours, unless directed by a doctor
￭do not use for more than 10 days unless directed by a doctor
 Children under 12 years Ask a doctor

Questions Or Comments ?

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Package Labeling:

Bottle (Bottle)

Bottle (Bottle)

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