Label: NIGHTTIME SLEEP AID- diphenhydramine hcl capsule
- NDC Code(s): 41250-260-32, 41250-260-64, 41250-260-96
- Packager: MEIJER, 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 January 16, 2023
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
- Uses
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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
†Compare to the active ingredient in Unisom® SleepGels®*
MAXIMUM STRENGTH
Sleep Aid
Diphenhydramine HCl | 50 mg
Nighttime Sleep-Aid
Safe, non-habit forming
SOFTGELS
ONE SOFTGELS PER DOSE
†This product is not manufactured or distributed by Chattem, Inc., distributor of 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.
DIST. BY MEIJER DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
- Product Label
-
INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP AID
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-260 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) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color blue Score no score Shape CAPSULE Size 13mm Flavor Imprint Code P50 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-260-64 1 in 1 BOX 11/29/2019 01/31/2025 1 64 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:41250-260-32 1 in 1 BOX 11/29/2019 01/31/2025 2 32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:41250-260-96 96 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/29/2019 01/31/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part338 11/29/2019 01/31/2025 Labeler - MEIJER, INC. (006959555)
