Label: SLEEP AID- diphenhydramine hcl capsule
- NDC Code(s): 30142-715-32, 30142-715-92, 30142-715-96
- Packager: The Kroger Co.
- 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 November 28, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each softgel)
- Purpose
- Use
-
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
COMPARE TO the active ingredient of UNISOM® SLEEPGELS®
*See bottom panel
Nighttime Sleep-Aid
Sleep-Aid Softgels
Diphenhydramine HCl 50 mg
Nighttime sleep-aid
Safe, Non-Habit Forming
maximum Strength
Help to Reduce
Difficulty Falling Asleep
SOFTGELS
liquid filled, one softgel per dose
*Unisom® SleepGels® is a registered trademark of Chattem, Inc., Chattanooga, TN 34709. Chattem, Inc., is not affiliated with The Kroger Co. or this product
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 THE KROGER CO.
CINCINNATI, OHIO 45202
- Package Label
-
INGREDIENTS AND APPEARANCE
SLEEP AID
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-715 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) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MANNITOL (UNII: 3OWL53L36A) Product Characteristics Color blue Score no score Shape CAPSULE Size 13mm Flavor Imprint Code PC5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-715-92 2 in 1 PACKAGE 03/26/2021 1 96 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:30142-715-32 1 in 1 BOX 03/26/2021 2 32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:30142-715-96 96 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/26/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 03/26/2021 Labeler - The Kroger Co. (006999528)