ZZZQUIL NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride liquid 
The Procter & Gamble Manufacturing Company

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.

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ZzzQuil™

NIGHTTIME SLEEP-AID

Drug Facts

Active ingredients
(in each 30 mL dose cup or 2 tablespoons)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

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

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

  • avoid alcoholic beverages

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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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

Questions?

1-877-881-5813

Dist. by Procter & Gamble,
Cincinnati OH 45202.

PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

NEW From the makers of VICKS ® NyQuil®

ZzzQuil

NIGHTTIME SLEEP-AID

Diphenhydramine HCl

Not for treating Cold or Flu

See Warnings

Alcohol 10%

12 FL OZ (354 ml)

500 New

ZZZQUIL  NIGHTTIME SLEEP-AID
diphenhydramine hydrochloride liquid
Product 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)

Revised: 9/2019
Document Id: 91bf189d-9ea0-3f89-e053-2a95a90a4508
Set id: e441c952-cd48-4159-ada2-271ca7541600
Version: 6
Effective Time: 20190904
 
The Procter & Gamble Manufacturing Company