General MedicineOTC AvailablePregnancy Cat. Not classifiedFDA Yes
Naproxen Sodium Diphenhydramine Hydrochloride
NAPROXEN SODIUM DIPHENHYDRAMINE HYDROCHLORIDE
Uses ■ for relief of occasional sleeplessness when asscoiated with minor aches and pains ■ helps you fall asleep and stay asleep
Medically reviewed by MedCentralHub Medical Review Board, Licensed Pharmacists & Physicians ·
Brand names:Naproxen Sodium Diphenhydramine Hydrochloride
Quick Reference
Medicine ClassGeneral Medicine
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- NAPROXEN SODIUM DIPHENHYDRAMINE HYDROCHLORIDE
- Medicine class
- General Medicine
- Brand names
- Naproxen Sodium Diphenhydramine Hydrochloride
- Availability
- Over-the-counter (OTC)
- Pregnancy category
- Not classified
- FDA approved
- Yes
Medical Review
Medically reviewed- Reviewed by
- MedCentralHub Medical Review Board
- Credentials
- Licensed Pharmacists & Physicians
- Last reviewed
- Next review
Written from primary sources (FDA labeling, NIH/MedlinePlus, peer-reviewed literature) and verified by our review board. Educational information only — not a substitute for professional medical advice. See our medical disclaimer.
What Is Naproxen Sodium Diphenhydramine Hydrochloride?
Uses ■ for relief of occasional sleeplessness when asscoiated with minor aches and pains ■ helps you fall asleep and stay asleep
Naproxen Sodium Diphenhydramine Hydrochloride (NAPROXEN SODIUM DIPHENHYDRAMINE HYDROCHLORIDE) belongs to the General Medicine class of medications. It was first approved by the FDA in Yes. This medication is available over-the-counter without a prescription.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Naproxen Sodium Diphenhydramine Hydrochloride. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Naproxen Sodium Diphenhydramine Hydrochloride with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Naproxen Sodium Diphenhydramine Hydrochloride is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
Uses ■ for relief of occasional sleeplessness when asscoiated with minor aches and pains ■ helps you fall asleep and stay asleep
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
Directions ■ do not take more than directed ■ drink a full glass of water with each dose ■ adults and children 12 years and over: take 2 caplets at bedtime do not take more than 2 caplets in 24 hours if taken with food, this product may take longer to work
Available Forms
Available Strengths
Side Effects
Common
Serious
- Allergy alert Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin.
- Symptoms may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock ■ skin reddening ■ rash ■ blisters If an allergic reaction occurs, stop use and seek medical help right away.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
Allergy alert Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock ■ skin reddening ■ rash ■ blisters If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding.
Heart attack and stroke warning NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
How Naproxen Sodium Diphenhydramine Hydrochloride Works
Pharmacokinetics
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Naproxen Sodium Diphenhydramine Hydrochloridewhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Other information ■ each caplet contains: sodium 20mg ■ read all warnings and directions before use. Keep outer carton. ■ store at 20 to 25 °C (68 to 77 °F) ■ avoid high humidity and excessive heat above 40 °C (104 °F)
Frequently Asked Questions
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Adult, pediatric, renal, and hepatic dosing for Naproxen Sodium Diphenhydramine Hydrochloride
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Naproxen Sodium Diphenhydramine Hydrochloride side effects
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Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Naproxen Sodium Diphenhydramine Hydrochloride
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Sources & References
Content on this page is drawn from the following primary sources and reviewed against current labeling.
- FDA DailyMed — Official FDA prescribing information and drug labels
- MedlinePlus (NIH) — Patient-friendly drug information from the National Library of Medicine
- FDA Drug Safety Communications — Current FDA safety alerts, recalls, and label changes
- PubMed — Peer-reviewed clinical literature
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.