Care One Ibuprofen PM 38 mg/1
diphenhydramine citrate and ibuprofen · TABLET, FILM COATED · American Sales Company
Care One Ibuprofen PM is a tablet, film coated containing diphenhydramine citrate and ibuprofen at 38 mg/1, taken oral. Manufactured by American Sales Company.
Key Facts
- Brand Name
- Care One Ibuprofen PM
- Generic Name
- diphenhydramine citrate and ibuprofen
- NDC Code (Product)
41520-050- Manufacturer
- American Sales Company
- Strength
- 38 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA079113
- Drug Class
- Nonsteroidal Anti-inflammatory Drug [EPC]
- Marketing Start
- 02/20/2009
Recall History
No Recall HistorySide 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 Care One Ibuprofen PM used for?
Care One Ibuprofen PM contains diphenhydramine citrate and ibuprofen. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Care One Ibuprofen PM a controlled substance?
Care One Ibuprofen PM is not classified as a controlled substance by the DEA.
What is the generic name for Care One Ibuprofen PM?
The generic name for Care One Ibuprofen PM is diphenhydramine citrate and ibuprofen. There are 5 other brand versions of diphenhydramine citrate and ibuprofen.
What is the NDC code for Care One Ibuprofen PM 38 mg/1?
The NDC (National Drug Code) for Care One Ibuprofen PM 38 mg/1 is 41520-050, listed by American Sales Company.