Label: NIGHTTIME SLEEP AID- diphenhydramine hcl capsule
- NDC Code(s): 69607-0916-6
- Packager: WR Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 11, 2024
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- Download DRUG LABEL INFO: PDF XML
- 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
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Principal Display Panel
†Compare to the Active Ingredient in Unisom® SleepGels®
NON HABIT-FORMING
NIGHTTIME
Sleep Aid
Diphenhydramine HCI 50 mg
FALL ASLEEP FAST | SLEEP SOUNDLY
WAKE UP REFRESHED
SOFTGELS**
ONE SOFTGEL PER DOSE
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
**This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.
MANUFACTURED FOR:
KOLBE & SCHMITT
9160 E. BAHIA DR. SCOTTSDALE, AZ 85260 USA
- Package Label
-
INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP AID
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69607-0916 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) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) LIGHT MINERAL OIL (UNII: N6K5787QVP) 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:69607-0916-6 96 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/06/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M010 08/06/2021 Labeler - WR Group, Inc. (089173699)