Active Ingredient (In Each Caplet)
Diphenhydramine citrate 38 mg
ibuprofen 200 mg(NSAID)*
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar (family Wellness) for the product Ibuprofen Pm (NDC 55319-197). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Diphenhydramine citrate 38 mg
ibuprofen 200 mg(NSAID)*
*nonsteroidal anti-inflammatory drug
Nighttime sleep-aid
Pain Reliever
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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:
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
ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
carnauba wax, corn starch, croscarmellose sodium,FD&C blue #1, hypromellose, microcrystalline cellulose, polydestrose, polyethylene glycol 400, silicon dioxide, stearic acid, titanium dioxide
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COMPARE TO THE ACTIVE INGREDIENTS IN ADVIL® PM†
IBUPROFEN PM
Ibuprofen 200 mg
Pain reliever (NSAID)
Diphenhydramine Citrate 38 mg
Nighttime sleep-aid
COATED CAPLET**
(**Capsules-Shaped Tablets)
†This product is not manufactured or distributed by Heleon Group of Companies, distributor Advil® PM.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY:
MIDWOOD BRAND LLC
500 VOLVO PHWY,
CHESAPEAKE, VA 23320
* Please review the disclaimer below.