FLO PMS Complete

FLO PMS Complete is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE. It is labelled by O Positiv, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 83049-489, application M013, label effective 20231009. It is one of 11 FDA drug label records sharing the active ingredient ACETAMINOPHEN, CAFFEINE, 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, PYRILAMINE MALEATE are most often described in connection with: temporary relief, symptoms associated, menstrual periods, bloating headache, muscle aches, cramps backache, fatigue water-weight. 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: • bloating • headache • muscle aches • cramps • backache • fatigue • water-weight gain

Directions • do not take more than the recommended dose • adults and children 12 years and over: • take 2 caplets with water • repeat every 6 hours, as needed • do not exceed 6 caplets per day • children under 12 years: ask a doctor

Warnings Liver warning : This product contains 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 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 • if you have ever had an allergic reaction to this product or any of its ingredients • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have • difficulty in urination due to enlargement of the prostate gland • liver disease • glaucoma • a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers When using this product • excitability may occur, especially in children • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness • you may get drowsy • 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. The recommended dose of this product contains about as much caffeine as a cup of coffee. • avoid alcoholic beverages Stop use and ask a doctor if • new symptoms occur • redness or swelling is present • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days 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 . In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

FDA lists 11 drug label records with ACETAMINOPHEN, CAFFEINE, 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 FLO PMS Complete used for?
Uses for the temporary relief of these symptoms associated with menstrual periods: • bloating • headache • muscle aches • cramps • backache • fatigue • water-weight gain

Who makes FLO PMS Complete?
O Positiv, Inc. is the labeler of record for FLO PMS Complete. 11 FDA label records share the active ingredient ACETAMINOPHEN, CAFFEINE, 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 FLO PMS Complete 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 FLO PMS Complete 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, PYRILAMINE MALEATE?
Yes. 11 FDA drug label records list ACETAMINOPHEN, CAFFEINE, 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 FLO PMS Complete 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.