Label: NIGHTTIME SLEEP AID- diphenhydramine hcl capsule
- NDC Code(s): 70000-0616-1
- Packager: Cardinal Health (Leader) 70000
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 23, 2024
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
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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
Sleep Aid
Diphenhydramine HCl, 50 mg
Nighttime Sleep-Aid
Fall Asleep Fast
Sleep Soundly
Wake Up Refreshed
Non-Habit-Forming
SOFTGELS
One Softgel Per Dose
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY CARDINAL HEALTH,
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
- Package Label
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INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP AID
diphenhydramine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0616 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:70000-0616-1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/28/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M010 10/28/2022 Labeler - Cardinal Health (Leader) 70000 (063997360)