Diphenhydramine HCl and Ibuprofen
Diphenhydramine HCl and Ibuprofen is an FDA drug label for the active ingredient DIPHENHYDRAMINE HCL AND IBUPROFEN manufactured by Aurohealth LLC 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 20221209.
Generic: DIPHENHYDRAMINE HCL AND IBUPROFEN
Manufacturer: Aurohealth LLC
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 58602-717
Application: ANDA210676
Effective: 20221209
Active Ingredients: Drug Facts Active ingredients (in each capsule) Diphenhydramine hydrochloride USP 25 mg Solubilized ibuprofen equal to 200 mg ibuprofen USP (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug
Indications & Usage
Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
Dosage & Administration
Directions do not take more than directed adults and children 12 years and over: take 2 capsules at bedtime do not take more than 2 capsules in 24 hours Other information each capsule contains: potassium 20 mg read all warnings and directions before use. store at 20° to 25°C (68° to 77°F) avoid excessive heat above 40°C (104°F) protect from light Organic Impurities Test is Pending Meets USP dissolution test 2
Contraindications
Not available.
Warnings
Warnings Allergy alert: Ibuprofen 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. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed. 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.
Adverse Reactions
Not available.
More from same ingredient
No related products.