Label: SLEEP AID- diphenhydramine hcl capsule
- NDC Code(s): 70677-1151-1
- Packager: Strategic Sourcing Services LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 30, 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 UNISOM® SLEEPGELS® ACTIVE INGREDIENT†
MAXIMUM STRENGTH
Sleep-Aid
Diphenhydramine HCl 50 mg
NIGHTTIME SLEEP-AID
For relief of occasional sleeplessness
Non habit-forming
SOFTGELS
ONE SOFTGEL PER DOSE
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
†This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.
Distributed by: Mckesson Corp.,
via Strategic Sourcing Services LLC.
Memphis TN 38141
www.fosterandthrive.com
- Package Label
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INGREDIENTS AND APPEARANCE
SLEEP AID
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1151 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 OVAL Size 13mm Flavor Imprint Code PC5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-1151-1 1 in 1 BOX 03/31/2023 1 32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M010 03/31/2023 Labeler - Strategic Sourcing Services LLC (116956644)