NDC | 37000-430-12, 37000-430-24 |
Set ID | 29bf8bed-1efe-4514-9dc9-b7087a1785d8 |
Category | HUMAN OTC DRUG LABEL |
Packager | The Procter & Gamble Manufacturing Company |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART338 |
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 30 mL dose cup)
- Purpose
- Uses
- for the relief of occasional sleeplessness
- 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 skin
Ask 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 gland
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.
Keep 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)
- only use the dose cup provided
adults & children 12 yrs & over 30 mL at bed time if needed or as directed by a doctor children under 12 yrs do not use - Other information
- Inactive ingredients
alcohol, citric acid anhydrous, FD&C Blue No. 1, FD&C Red No. 40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate
Close - Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label
NEW
FLAVORFrom the makers of VICKS ® NyQuil™
ZzzQuil™
NIGHTTIME SLEEP-AID
Diphenhydramine HCl
Non-Habit Forming
Calming Vanilla Cherry
Not for treating Cold or Flu
Alcohol 10%12 FL OZ (354 ml)
- INGREDIENTS AND APPEARANCE
ZZZQUIL NIGHTTIME SLEEP-AID
diphenhydramine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-430 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 in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color red Score Shape Size Flavor VANILLA, CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-430-12 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/03/2015 2 NDC:37000-430-24 2 in 1 CELLO PACK 02/03/2015 2 354 mL in 1 BOTTLE, PLASTIC; 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 02/03/2015 Labeler - The Procter & Gamble Manufacturing Company (004238200)