Pain Relief PM Extra Strength 500 mg/1
Acetaminophen 500 mg and Diphenhydramine HCl 25 mg · TABLET · Allegiant Health
Pain Relief PM Extra Strength is an over-the-counter tablet that combines acetaminophen (a pain reliever and fever reducer) with diphenhydramine (an antihistamine that causes drowsiness) to help relieve minor aches and pains while promoting sleep. This medication is taken by mouth and is intended for nighttime pain relief in adults and children 12 years and older.
Key Facts
- Brand Name
- Pain Relief PM Extra Strength
- Generic Name
- Acetaminophen 500 mg and Diphenhydramine HCl 25 mg
- NDC Code (Product)
69168-393- Manufacturer
- Allegiant Health
- Strength
- 500 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- M013
- Marketing Start
- 12/23/2014
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Dosage & Administration
Directions do not take more than directed adults and children 12 years and over take 2 gelcaps at bedtime do not take more than 2 gelcaps 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 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. with any other product containing diphenhydramine, even one used on skin in children under 12 years of age Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland 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 will occur avoid alcoholic beverages do not drive a motor vehicle or operate machinery Stop use and ask a doctor if sleeplessness persi…
Frequently Asked Questions
What is Pain Relief PM Extra Strength used for?
Pain Relief PM Extra Strength is an over-the-counter tablet that combines acetaminophen (a pain reliever and fever reducer) with diphenhydramine (an antihistamine that causes drowsiness) to help relieve minor aches and pains while promoting sleep. This medication is taken by mouth and is intended for nighttime pain relief in adults and children 12 years and older.
Is Pain Relief PM Extra Strength a controlled substance?
Pain Relief PM Extra Strength is not classified as a controlled substance by the DEA.
What is the generic name for Pain Relief PM Extra Strength?
The generic name for Pain Relief PM Extra Strength is Acetaminophen 500 mg and Diphenhydramine HCl 25 mg. There are no other listed brand versions of Acetaminophen 500 mg and Diphenhydramine HCl 25 mg.
What is the NDC code for Pain Relief PM Extra Strength 500 mg/1?
The NDC (National Drug Code) for Pain Relief PM Extra Strength 500 mg/1 is 69168-393, listed by Allegiant Health.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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