CounterAct PM
CounterAct PM is an FDA drug label for the active ingredient ACETAMINOPHEN AND DIPHENHYDRAMINE manufactured by Melaleuca, Inc. 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 20190118.
- Generic name
- ACETAMINOPHEN AND DIPHENHYDRAMINE
- Manufacturer
- Melaleuca, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 54473-304
- Application
- part343
- Label effective
- 20190118
About this product
CounterAct PM is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN AND DIPHENHYDRAMINE. It is labelled by Melaleuca, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 54473-304, application part343, label effective 20190118. 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 AND DIPHENHYDRAMINE are most often described in connection with: temporary relief, occassional headaches, minor aches, accompanying sleeplessness. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses temporary relief of occassional headaches, minor aches, and pains with accompanying sleeplessness
Dosage & Administration
Directions do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. children under 12 years: do not use.
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, which is the maimum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product
Frequently asked questions
What is CounterAct PM used for?
Uses temporary relief of occassional headaches, minor aches, and pains with accompanying sleeplessness
Who makes CounterAct PM?
Melaleuca, Inc. is the labeler of record for CounterAct PM.
What form does CounterAct PM 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 CounterAct PM 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.
Has CounterAct PM 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.