Label: NIGHTTIME SLEEP-AID SOFTGEL- diphenhydramine hydrochloride capsule, liquid filled
- NDC Code(s): 51316-779-24, 51316-779-48
- Packager: CVS PHARMACY, INC
- Category: HUMAN OTC DRUG LABEL
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 July 22, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- 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 • glaucoma • heart diseases • a breathing problem such as emphysema, asthma, or chronic bronchitis • difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers, or any other sleep aid
When using this product avoid alcoholic beverages and other drugs that cause drowsiness. Be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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SPL UNCLASSIFIED SECTION
Compare to the active ingredient in Vicks® ZzzQuil™ NIGHTTIME SLEEP-AID LiquidCaps™**
Non-habit forming
Not for treating pain, cold or flu
**This product is not manufactured or distributed by The Proctor & Gamble Company, owner of the registered trademark VICKS® ZzzQuil™ NIGHTTIME SLEEP-AID LiquiCaps™.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING
READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Product of UAE
Packaged and Quality Assured in the USA
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2021 CVS/pharmacy
CVS.com®
1-800-SHOP CVS - Packaging
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INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP-AID SOFTGEL
diphenhydramine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-779 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, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL ALCOHOL (UNII: ND2M416302) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color purple Score no score Shape OVAL Size 16mm Flavor Imprint Code 779 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-779-24 2 in 1 CARTON 07/23/2021 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:51316-779-48 4 in 1 CARTON 07/23/2021 2 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 part338 07/23/2021 Labeler - CVS PHARMACY, INC (062312574)
