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ZZZQUIL NIGHTTIME SLEEP-AID (diphenhydramine hydrochloride) capsule, gelatin coated
[Procter & Gamble Manufacturing Company]


NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

Drug Facts

Active ingredients (in each liquicap)

Diphenhydramine HCl 25 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.
  • do not use with NyQuil
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have

  • a breathing problem such as asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid

When using this product

  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery

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: Taking more than directed can cause serious health problems. 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
adults & children
12 yrs & over
One dose = TWO 25 mg LiquiCaps (50 mg)
at bed time if needed or as directed by a doctor

Other information

  • store at 20-25° C (68-77° F)
  • avoid excessive heat above 40° C (104° F) and high humidity
  • Protect from light

Inactive ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, red #40, sorbitol, titanium dioxide

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

Principal Display Panel - 12 Capsule Carton

INGREDIENTS & APPEARANCE

ZZZQUIL   NIGHTTIME SLEEP-AID
diphenhydramine hydrochloride capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37000-501
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride50 mg  in 2 
Inactive Ingredients
Ingredient NameStrength
FD&C Blue No. 1 
gelatin 
glycerin 
polyethylene glycols 
water 
FD&C Red No. 40 
sorbitol 
titanium dioxide 
Product Characteristics
ColorPURPLEScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code Zzz
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-501-126 in 1 CARTON
12 in 1 BLISTER PACK
2NDC:37000-501-2412 in 1 CARTON
22 in 1 BLISTER PACK
3NDC:37000-501-4824 in 1 CARTON
32 in 1 BLISTER PACK
4NDC:37000-501-7236 in 1 CARTON
42 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33812/08/2011
Labeler - Procter & Gamble Manufacturing Company (004238200)

Revised: 6/2013
 
Procter & Gamble Manufacturing Company