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

Premier Value Nighttime Sleep Aid Softgels by

Drug Labeling and Warnings

Premier Value Nighttime Sleep Aid Softgels by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

PREMIER VALUE NIGHTTIME SLEEP AID SOFTGELS 
diphenhydramine hydrochloride capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-218
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	50 mg  in 2

Inactive Ingredients
Ingredient Name	Strength
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
Color	PURPLE	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	R060
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-218-25	12 in 1 CARTON	11/14/2014
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	11/14/2014

Labeler - Chain Drug Consortium (101668460)