SafeTynadol

SafeTynadol is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN. It is labelled by Sinew Pharma Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 81389-001, application M013, label effective 20231028. It is one of 274 FDA drug label records sharing the active ingredient ACETAMINOPHEN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ACETAMINOPHEN are most often described in connection with: temporarily relieves, minor aches, pains due, common cold, headache backache, pain arthritis, toothache premenstrual, menstrual cramps. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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

Warnings 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 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. Liver warning: Allergy alert: 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.

FDA lists 274 drug label records with ACETAMINOPHEN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is SafeTynadol used for?
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

Who makes SafeTynadol?
Sinew Pharma Inc. is the labeler of record for SafeTynadol. 274 FDA label records share the active ingredient ACETAMINOPHEN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does SafeTynadol come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is SafeTynadol prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ACETAMINOPHEN?
Yes. 274 FDA drug label records list ACETAMINOPHEN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has SafeTynadol been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.