PREMIER VALUE NIGHTTIME SLEEP AID SOFTGELS- diphenhydramine hydrochloride capsule, gelatin coated 
Chain Drug Consortium

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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PREMIER VALUE SLEEP-AID SOFTGELS

Drug Facts

Active ingredients (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

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 Softgels (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, FD&C red 40, gelatin, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sorbitol, titanium dioxide

Failure to follow these warnings could result in serious consequences

TAMPER EVIDENT: This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

Distributed by:

Chain Drug Consortium LLC.

3301 N.W. Boca Raton Blvd.

Suite 101, Boca Raton FL 33431

*This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil® Liquicaps.

PRINCIPAL DISPLAY PANEL

Premier Value
Nighttime

Sleep-Aid Softgels
Diphenhydramine HCl

Non Habit Forming

Not for treating Cold or Flu

See Warnings

Compare to ZzzQuil® Liquicaps® active ingredient*

24 SOFTGELS

Premier Value Nighttime Sleep-Aid Softgel
PREMIER VALUE NIGHTTIME SLEEP AID SOFTGELS 
diphenhydramine hydrochloride capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-218
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)  
FD&C Red No. 40 (UNII: WZB9127XOA)  
gelatin (UNII: 2G86QN327L)  
glycerin (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
polyethylene glycols (UNII: 3WJQ0SDW1A)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
sorbitol (UNII: 506T60A25R)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPURPLEScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code R060
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-218-2512 in 1 CARTON11/14/2014
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33811/14/2014
Labeler - Chain Drug Consortium (101668460)

Revised: 6/2016
Document Id: 165a2e49-73d2-481f-b4ce-d6597c23e009
Set id: a6e94bea-7348-4b09-9244-9ef7b31a16b4
Version: 2
Effective Time: 20160615
 
Chain Drug Consortium