Comfort-Time

Comfort-Time is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE. It is labelled by Time Cap Labs, Inc taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 49483-347, application part343, label effective 20181214. It is one of 2 FDA drug label records sharing the active ingredient ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE. 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, AND PYRILAMINE MALEATE are most often described in connection with: temporary relief, symptoms associated, menstrual periods, cramps bloating, water-weight gain, headache backache, breast tenderness, fatigue muscle. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses for the temporary relief of these symptoms associated with menstrual periods: cramps bloating water-weight gain headache backache breast tenderness fatigue muscle aches

Uses for the temporary relief of these symptoms associated with menstrual periods: cramps bloating water-weight gain headache backache breast tenderness fatigue muscle aches

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product

FDA lists 2 drug label records with ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE 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 Comfort-Time used for?
Uses for the temporary relief of these symptoms associated with menstrual periods: cramps bloating water-weight gain headache backache breast tenderness fatigue muscle aches

Who makes Comfort-Time?
Time Cap Labs, Inc is the labeler of record for Comfort-Time. 2 FDA label records share the active ingredient ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE, 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 Comfort-Time 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 Comfort-Time 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, AND PYRILAMINE MALEATE?
Yes. 2 FDA drug label records list ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE 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 Comfort-Time 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.