ZZZQUIL ALCOHOL FREE NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride solution 
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™

Alcohol Free Nighttime Sleep-Aid

Drug Facts

Active ingredient (in each 30 mL dose cup)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

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

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 a serious underlying medical illness.

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

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 & over30 mL at bed time if needed or as directed by a doctor
    children under 12 yrsdo not use

Other information

  • each 30 mL contains:

    sodium 24 mg
  • store at controlled room temperature

Inactive ingredients

citric acid anhydrous, FD&C Blue No. 1, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate

Questions or comments?

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™

ALCOHOL FREE

NIGHTTIME SLEEP-AID

Diphenhydramine HCl

  • Non-Habit Forming

Soothing Mango Berry

Not for treating Cold or Flu

12 FL OZ (354 ml)

431 NEW

ZZZQUIL  ALCOHOL FREE NIGHTTIME SLEEP-AID
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-431
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
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)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorMANGO (Berry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-431-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/201504/19/2023
2NDC:37000-431-242 in 1 PACKAGE, COMBINATION02/03/201504/19/2023
2NDC:37000-431-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:37000-431-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/201504/19/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01002/03/201504/19/2023
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 6/2023
Document Id: fe304bc1-e74a-d206-e053-6294a90a0930
Set id: 7b0cc06d-c1bd-415b-953f-6f89adbb2e59
Version: 9
Effective Time: 20230615
 
The Procter & Gamble Manufacturing Company