Ibuprofen PM 25 mg/1
IBUPROFEN, DIPHENHYDRAMINE HCL · CAPSULE, LIQUID FILLED · Premier Value Alliance LLC
Ibuprofen PM is an over-the-counter pain reliever and nighttime sleep aid that combines ibuprofen, a nonsteroidal anti-inflammatory drug, with diphenhydramine, an antihistamine that causes drowsiness. It is used to temporarily relieve minor aches and pains while helping you fall asleep.
Key Facts
- Brand Name
- Ibuprofen PM
- Generic Name
- IBUPROFEN, DIPHENHYDRAMINE HCL
- NDC Code (Product)
68016-057- Manufacturer
- Premier Value Alliance LLC
- Strength
- 25 mg/1
- Dosage Form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090397
- Drug Class
- Nonsteroidal Anti-inflammatory Drug [EPC]
- Marketing Start
- 10/25/2018
Recall History
Family Dollar Stores, Llc.
CGMP Deviations: product held outside appropriate storage temperature conditions.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 caplets at bedtime • do not take more than 2 caplets in 24 hours
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. 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 …
Frequently Asked Questions
What is Ibuprofen PM used for?
Ibuprofen PM is an over-the-counter pain reliever and nighttime sleep aid that combines ibuprofen, a nonsteroidal anti-inflammatory drug, with diphenhydramine, an antihistamine that causes drowsiness. It is used to temporarily relieve minor aches and pains while helping you fall asleep.
Is Ibuprofen PM a controlled substance?
Ibuprofen PM is not classified as a controlled substance by the DEA.
What is the generic name for Ibuprofen PM?
The generic name for Ibuprofen PM is IBUPROFEN, DIPHENHYDRAMINE HCL. There are 5 other brand versions of IBUPROFEN, DIPHENHYDRAMINE HCL.
What is the NDC code for Ibuprofen PM 25 mg/1?
The NDC (National Drug Code) for Ibuprofen PM 25 mg/1 is 68016-057, listed by Premier Value Alliance LLC.