SLEEP TIME- diphenhydramine hcl capsule, liquid filled 
HyVee Inc

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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Hy-Vee, Inc. Sleep Time Drug Facts

Active ingredient (in each softgel)

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
•
with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
•
with other Nighttime products

Ask a doctor before use if you have

•
a breathing problem such as emphysema or chronic bronchitis
•
glaucoma
•
difficulty in urination due to an 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:Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

•
take only one dose per day (24 hours) – see Overdose warning
 
adults & children 12 yrs & over

One dose = TWO 25 mg Softgels (50 mg) at bedtime if needed or as directed by a doctor

Other information

•
avoid excessive heat above 40°C (104°F) and high humidity
•
protect from light

Inactive ingredients

edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Vicks® ZzzQuil® Nighttime Sleep-Aid active ingredient

Sleep Time

Night Time Sleep-Aid

Diphenhydramine HCl 25 mg

Non-Habit Forming

Not for Treating Cold or Flu

See Warnings

12 SOFTGELS

Sleep Time Image 1
Sleep Time Image 2
SLEEP TIME 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-052
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorPURPLEScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code 052
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42507-052-536 in 1 CARTON02/01/201408/01/2016
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:42507-052-6724 in 1 CARTON02/01/201408/01/2016
22 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33802/01/201408/01/2016
Labeler - HyVee Inc (006925671)

Revised: 11/2017
Document Id: 8104eea8-d019-469a-8b5f-8a0d79e6601b
Set id: 5e71d345-2d68-433a-88ca-4a324c02c38d
Version: 2
Effective Time: 20171118
 
HyVee Inc