Label: NIGHTTIME SLEEP AID MAXIMUM STRENGTH- diphenhydramine hydrochloride capsule, liquid filled
- NDC Code(s): 50804-236-03
- Packager: Good Sense (Geiss, Destin & Dunn, Inc.)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 28, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each softgel)
- Purpose
- Use
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Warnings
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Maximum Strength
Nighttime
Sleep-Aid
Diphenhydramine HCl, 50 mg
Nighttime Sleep-Aid
Helps to reduce difficulty falling asleep
Softgels (50 mg Each)
Gluten Free
†Compare to active ingredient in Unisom® SleepGels®
Distributed by: Geiss, Destin & Dunn, Inc.
Peachtree City, GA 30269
†This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
- Product Label
-
INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP AID MAXIMUM STRENGTH
diphenhydramine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-236 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) LIGHT MINERAL OIL (UNII: N6K5787QVP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color blue Score no score Shape OVAL Size 13mm Flavor Imprint Code P50;A99;S90 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50804-236-03 1 in 1 BOX 02/01/2014 02/01/2025 1 32 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/01/2014 02/01/2025 Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836)