Active Ingredients (In Each Caplet)
Acetaminophen 500 mg*
Diphenhydramine HCl 25 mg**
Pain Relief Pm
FDA Label NDC 63548-2341
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Avema Pharma Solutions for the product Pain Relief Pm (NDC 63548-2341). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
*Pain reliever
**Nighttime sleep aid
Uses
Temporary relief of occasional headaches, minor aches, and pains accompanying sleeplessness.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur with this product if you take:
- more than 2 caplets 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
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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 children even if you do not notice any signs or symptoms.
Do Not Use
- with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- in children under 12 years of age
- with other products containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
- liver disease
- asthma
- breathing problems such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urinating due to an enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When Using This Product
avoid alcoholic beverages
do not drive a motor vehicle or operate machinery. This product will cause drowsiness.
Stop Use And Ask A Doctor If
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- new symptoms occur
- redness or swelling is present
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children.
Directions
- do not exceed recommended dose
- adults and children 12 years of age and over: take 2 caplets at bedtime. Do not take more than 2 caplets in 24 hours.
- children under 12 years of age: do not use this product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage.
Other Information
- store at room temperature 15°-30°C (59°-86°F), avoid high humidity and excessive heat
- do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients
FD&C Blue #1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), polyvinyl alcohol, polyvinylpyrrolidone, sodium carboxymethyl starch, starch, stearic acid, talc, titanium dioxide.
Package/Label Principal Display Panel
Pain Relief Pm Packaging Label (691c5587 3994 45e2 A669 608ba7a98bfb 01)
NDC 63548-2341-*1
SEE NEW WARNINGS INFORMATION
EXTRA STRENGTH
Pain Relief PM
Pain reliever
Nighttime Sleep-Aid
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
24 CAPLETS
Do not use if imprinted safety seal under cap is broken or missing
* Please review the disclaimer below.
