Syncol Max

ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE ORAL HUMAN OTC DRUG

Syncol Max is an FDA drug label for the active ingredient ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE manufactured by Laboratorios Sanfer, S.A. de C.V. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260420.

Generic name
ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE
Manufacturer
Laboratorios Sanfer, S.A. de C.V.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
83393-390
Application
M027
Label effective
20260420

About this product

Syncol Max is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE. It is labelled by Laboratorios Sanfer, S.A. de C.V. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 83393-390, application M027, label effective 20260420. 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.

What it is used for

Across FDA labelling, products containing ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE are most often described in connection with: temporary relief, symptoms associated, menstrual periods, bloating headache, water-weight gain, cramps backache, fatigue muscle. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredients (in each caplet) Acetaminophen 500 mg Caffeine 60 mg Pyrilamine maleate 15 mg

Indications & Usage

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

Dosage & Administration

Directions do not take more than directed 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

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 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 have ever had an allergic reaction to this product or any of its ingredients 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 drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness excitability may occur, especially in children use caution when driving a motor vehicle or operating machinery 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 heart rate. The recommended dose of this product contains about as much caffeine as a cup of coffee. 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 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.

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ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE

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How products containing ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE compare

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.

Dosage formProductsManufacturerProducts
— — Better Living Brands, LLC 1
— — CVS Pharmacy 1
— — CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 1
— — Family Dollar Services Inc 1
— — H E B 1

Frequently asked questions

What is Syncol Max used for?
Uses for the temporary relief of these symptoms associated with menstrual periods: bloating headache water-weight gain cramps backache fatigue muscle aches

Who makes Syncol Max?
Laboratorios Sanfer, S.A. de C.V. is the labeler of record for Syncol Max. 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 Syncol Max 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 Syncol Max 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 Syncol Max 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.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.