RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief
RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief is an FDA drug label for the active ingredient ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE manufactured by Strive Pharmaceuticals 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 20231113.
- Generic name
- ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
- Manufacturer
- Strive Pharmaceuticals Inc.
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 70692-149
- Application
- M013
- Label effective
- 20231113
Active ingredients
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) • do not take more than 2 caplets in 24 hours adults & children 12 years of age and over • take 2 caplets at bedtime • do not take more than 2 caplets of this product in 24 hours children under 12 years of age 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 a 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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Adverse Reactions
Not available.