Label: NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride capsule, liquid filled
- NDC Code(s): 51013-104-02
- Packager: PuraCap Pharmaceutical LLC
- 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 December 2, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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
- with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
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
- heart disease
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid
When using this product
- avoid alcoholic beverages and other drugs that cause drowsiness
- drowsiness will occur
- be careful when driving a motor vehicle or operating machinery
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL
Nighttime Sleep-Aid
Diphenhydramine HCl, 25 mgCompare to Vicks® ZzzQuil® LiquiCaps® Active Ingredient*
12 Softgels
NDC 51013-104-02
Distributed by: Greenbrier International, Inc.
500 Volvo Parkway, Chesapeake, VA 23320
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® ZzzQuil® LiquiCaps®.
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INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP-AID
diphenhydramine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51013-104 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color purple Score no score Shape CAPSULE (oblong) Size 14mm Flavor Imprint Code PC11 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51013-104-02 1 in 1 CARTON 05/26/2015 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/26/2015 Labeler - PuraCap Pharmaceutical LLC (962106329) Establishment Name Address ID/FEI Business Operations Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd 421293287 MANUFACTURE(51013-104) , ANALYSIS(51013-104)