![ZZZQUIL NIGHTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [NAVAJO MANUFACTURING COMPANY INC.]](https://medic.hrt.org//dailymed/images/a8b12f40-38a4-4dad-b74b-d8c7604724fc/ZzzQuil.jpg)
| NDC | 67751-156-01 |
| Set ID | a8b12f40-38a4-4dad-b74b-d8c7604724fc |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Navajo Manufacturing Company Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART338 |
- Drug Facts
- Active ingredient (in each LiquiCap)
- Uses
• for the relief of occasional sleeplessness
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• reduces time to fall asleep if you have difficulty falling asleep - Warnings
Do not use
• for children under 12 years of age
• with any other product containing diphenhydramine, even one used on skinAsk a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate glandStop use and ask a doctor if
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
CloseKeep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- Directions
take only one dose per day (24 hours)
Closeadults & children 12 yrs & over 2 LiquiCaps at bedtime if needed or as directed by a doctor children under 12 yrs do not use - Other information
- Inactive ingredients
FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
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- Package Labeling:
- INGREDIENTS AND APPEARANCE
ZZZQUIL NIGHTIME SLEEP-AID
diphenhydramine hydrochloride capsule, gelatin coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67751-156(NDC:37000-501) 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) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color purple Score no score Shape CAPSULE Size 15mm Flavor Imprint Code Zzz Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67751-156-01 1 in 1 CARTON 09/29/2016 1 2 in 1 POUCH; 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 09/29/2016 CloseLabeler - Navajo Manufacturing Company Inc. (091917799)
