Premier value nighttime sleep aid softgels capsule, gelatin coated

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

Otc - do not use section

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

Otc - ask doctor section

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

Otc - ask doctor/pharmacist section

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

Otc - when using section

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

Otc - stop use section

Stop use and ask a doctor ifsleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Otc - pregnancy or breast feeding section

If pregnant or breast-feeding, ask a health professional before use.

Otc - keep out of reach of children section

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.

Ingredients and appearance - Product information

Premier value nighttime sleep aid softgels capsule, gelatin coated- Diphenhydramine hydrochloride

Product information

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

Active Ingredient/Active Moiety

Ingredient Name Strength
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 50 mgin 2

Inactive Ingredients

Ingredient Name Code
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 Size 15 mm
Shape CAPSULE Score 1
Imprint Code R060

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part338 USA

Labeler - Chain Drug Consortium( 101668460)

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