Drug Facts
Active ingredients
(in each caplet)
Diphenhydramine citrate USP 38 mg
Ibuprofen USP 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Better Living Brands, Llc for the product Ibuprofen And Diphenhydramine Citrate (NDC 21130-228). 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 drug facts, purposes, 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.
Active ingredients
(in each caplet)
Diphenhydramine citrate USP 38 mg
Ibuprofen USP 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.
Other information
carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue # 2, glyceryl dibehenate, hypromellose, lactose monohydrate, microcrystalline cellulose, palmitic acid, polydextrose, polyethylene glycol, pregelatinized starch (maize), sodium lauryl sulfate, sodium starch glycolate, stearic acid, and titanium dioxide.
Questions or comments?
Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)
DISTRIBUTED BY:
BETTER LIVING BRANDS LLC
P.O.BOX 99, PLEASANTON
CA 94566-0009
‡1-888-723-3929
Made in India
Code: TS/DRUGS/16/2014
Compare to Advil® PM
active ingredients †
Signature
care®
Quality NDC 21130-228-73
Guaranteed
IBUPROFEN AND
DIPHENHYDRAMINE CITRATE
TABLETS 200 mg/38 mg
Actual size
Pain Reliever (NSAID)/ 20 Coated Caplets**
Nighttime Sleep-Aid **Capsule-Shaped Tablets
* Please review the disclaimer below.