Drug Facts
Composition & Profile
Identifiers & Packaging
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 25 mg/200 mg (20 Liquid-Filled Capsules) Bottle Label NDC 58602-814-73 Diphenhydramine HCl and Ibuprofen Capsules USP 25 mg/200 mg Nighttime Sleep-Aid/ Pain Reliever (NSAID) 20 Liquid Filled Capsules READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION AUROHEALTH PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 25 mg/200 mg (20 Liquid-Filled Capsules) Bottle Label; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 25 mg/200 mg (20 Liquid-Filled Capsules) Bottle Carton Label NDC 58602-814-73 Diphenhydramine HCl and Ibuprofen Capsules USP 25 mg/200 mg Nighttime Sleep-Aid/Pain Reliever (NSAID) AUROHEALTH 20 Liquid Filled Capsules PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 25 mg/200 mg (20 Liquid-Filled Capsules) Bottle Carton Label
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 25 mg/200 mg (20 Liquid-Filled Capsules) Bottle Label NDC 58602-814-73 Diphenhydramine HCl and Ibuprofen Capsules USP 25 mg/200 mg Nighttime Sleep-Aid/ Pain Reliever (NSAID) 20 Liquid Filled Capsules READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION AUROHEALTH PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 25 mg/200 mg (20 Liquid-Filled Capsules) Bottle Label
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 25 mg/200 mg (20 Liquid-Filled Capsules) Bottle Carton Label NDC 58602-814-73 Diphenhydramine HCl and Ibuprofen Capsules USP 25 mg/200 mg Nighttime Sleep-Aid/Pain Reliever (NSAID) AUROHEALTH 20 Liquid Filled Capsules PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 25 mg/200 mg (20 Liquid-Filled Capsules) Bottle Carton Label
Overview
Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
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. Keep carton. 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
Warnings & Precautions
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.
Purpose
Purposes Nighttime sleep-aid Pain reliever
Do Not Use
Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer unless you have time for a full night's sleep in children under 12 years of age right before or after heart surgery with any other product containing diphenhydramine, even one used on skin if you have sleeplessness without pain
When Using
When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery take with food or milk if stomach upset occurs
Stop Use & Ask a Doctor
Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. redness or swelling is present in the painful area any new symptoms appear
Keep Out of Reach of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. [1-800-222-1222]
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