NOTTS - Tension Headache

NOTTS - Tension Headache is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, CAFFEINE. It is labelled by VIVUNT PHARMA LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 82706-010, application M013, label effective 20231124. It is one of 3 FDA drug label records sharing the active ingredient ACETAMINOPHEN, CAFFEINE. 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, CAFFEINE are most often described in connection with: temporary relief, minor aches, pains due, common cold, headache toothache, backaches premenstrual, menstrual cramps. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses For the temporary relief of minor aches and pains due to: common cold headache toothache muscular aches backaches premenstrual and menstrual cramps minor pain from arthritis

Directions Do not use more than directed Do not take more than 6 caplets in 24 hours, or as directed by a doctor adults and children 12 years and over take 2 caplets every 6 hours children under 12 years ask a doctor

Warnings Liver Warning: Liver warning: This product contains acetaminophen. Severe damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day ehile using this product. Allergy alert: Acetaminophen may cause severe sking reactions. Symptoms may include: skin reddening rash blisters. If a skin reactions occurs, stop use and seek medical attention immediately Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness. and occasionally, rapid heartbeat. Do not use with any other drug containing acetaminophen (prescription or nonprescription). 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. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition If pregnant or breast-feeding, ask a healt professional before use. Keep out of the reach of children Overdose warning: Do not take more than recommended dosage. In case of overdose, get medical help or contact a Poison Control Center. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

FDA lists 3 drug label records with ACETAMINOPHEN, CAFFEINE 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 NOTTS - Tension Headache used for?
Uses For the temporary relief of minor aches and pains due to: common cold headache toothache muscular aches backaches premenstrual and menstrual cramps minor pain from arthritis

Who makes NOTTS - Tension Headache?
VIVUNT PHARMA LLC is the labeler of record for NOTTS - Tension Headache. 3 FDA label records share the active ingredient ACETAMINOPHEN, CAFFEINE, 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 NOTTS - Tension Headache 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 NOTTS - Tension Headache 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, CAFFEINE?
Yes. 3 FDA drug label records list ACETAMINOPHEN, CAFFEINE 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 NOTTS - Tension Headache 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.