Label: QUALITY CHOICE NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride capsule, liquid filled
- NDC Code(s): 63868-970-24
- Packager: Chain Drug Marketing Association, Inc.
- 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 July 25, 2023
If you are a consumer or patient 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 active ingredient in VICKS® ZzzQUIL™ Liquicaps™
Non-habit Forming
Fall Asleep FastREAD AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
*This product is not manufactured or distributed by The Proctor & Gamble Company. ZzzQUIL™ is the registered trademark of The Proctor and Gamble Company.
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
QC 100% SATISFACTION GUARANTEED
Distributed by CDMA, Inc.
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362Product of UAE
Packaged and Quality Assured in the USAREV.01-092022
- Packaging
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INGREDIENTS AND APPEARANCE
QUALITY CHOICE NIGHTTIME SLEEP-AID
diphenhydramine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-970 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 15mm Flavor Imprint Code 779 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-970-24 2 in 1 CARTON 03/28/2023 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 part338 03/28/2023 Labeler - Chain Drug Marketing Association, Inc. (011920774)
