Pain Relief PM
Pain Relief PM is an FDA drug label for the active ingredient ACETAMINOPHEN, DIPHENHYDRAMINE HCL manufactured by DOLGENCORP, 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 20231222.
Generic: ACETAMINOPHEN, DIPHENHYDRAMINE HCL
Manufacturer: DOLGENCORP, INC.
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 55910-834
Application: M013
Effective: 20231222
Active Ingredients: Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg
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. 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
Contraindications
Not available.
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 if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma 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 drinks do not drive a motor vehicle or operate machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Adverse Reactions
Not available.
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