ZZZQUIL NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride capsule, gelatin coated 
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.

----------

ZzzQuil™

NIGHTTIME SLEEP-AID

Drug Facts

Active ingredients (in each liquicap)

Diphenhydramine HCl 25 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. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults & children 12 yrs & over

One dose = TWO 25 mg LiquiCaps (50 mg) at bed time 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, pharmaceutical ink*, polyethylene glycol, purified water, sorbitol sorbitan solution.
*May contain this ingredient.

Questions?

1-877-881-5813

Dist. by Procter & Gamble, Cincinnati OH 45202.

PRINCIPAL DISPLAY PANEL - 12 Capsule Carton

NEW From the makers of VICKS ® NyQuil ®

ZzzQuil

NIGHTTIME SLEEP-AID

Diphenhydramine HCl

Non-Habit Forming

See Warnings

Not for treating Cold or Flu

12 LiquiCaps

501 New

ZZZQUIL  NIGHTTIME SLEEP-AID
diphenhydramine hydrochloride capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-501
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 2 
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpurpleScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code Zzz
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-501-126 in 1 CARTON12/08/2011
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:37000-501-2412 in 1 CARTON12/08/2011
22 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:37000-501-4824 in 1 CARTON12/08/2011
32 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:37000-501-7236 in 1 CARTON12/08/2011
42 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:37000-501-962 in 1 CELLO PACK01/01/2020
524 in 1 CARTON
52 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33812/08/2011
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 2/2020
Document Id: 9fa4b5fc-e23f-e18a-e053-2995a90a7db6
Set id: ad4babdb-d98d-420e-b8b0-9a5368c89a44
Version: 11
Effective Time: 20200228
 
The Procter & Gamble Manufacturing Company