NDC | 37000-500-06, 37000-500-12, 37000-500-24, 37000-500-36 |
Set ID | e441c952-cd48-4159-ada2-271ca7541600 |
Category | HUMAN OTC DRUG LABEL |
Packager | The Procter & Gamble Manufacturing Company |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART338 |
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each 30 mL dose cup or 2 tablespoons)
- 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 serious underlying medical illness.
Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away.
- Directions
- take only one dose per day (24 hours) - see Overdose warning
- only use dose cup provided
adults & children 12 yrs & over
30 mL at bed time if needed or as directed by a doctorchildren under 12 yrs
do not use
Close - 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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label
NEW From the makers of VICKS ® NyQuil®
ZzzQuil™
NIGHTTIME SLEEP-AID
Diphenhydramine HCl
- Non-Habit Forming
- Warming Berry Flavor
Not for treating Cold or Flu
See Warnings
Alcohol 10%12 FL OZ (354 ml)
- INGREDIENTS AND APPEARANCE
ZZZQUIL NIGHTTIME SLEEP-AID
diphenhydramine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-500 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALCOHOL (UNII: 3K9958V90M) 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) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) Product Characteristics Color purple Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-500-06 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/08/2011 2 NDC:37000-500-12 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/08/2011 3 NDC:37000-500-24 2 in 1 PACKAGE, COMBINATION 12/08/2011 3 NDC:37000-500-12 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:37000-500-36 3 in 1 PACKAGE, COMBINATION 12/08/2011 4 NDC:37000-500-12 354 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 12/08/2011 Labeler - The Procter & Gamble Manufacturing Company (004238200)