NIGHTTIME SLEEP AID- diphenhydramine hcl tablet 
Chain Drug Consortium, LLC

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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DRUG FACTS

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

  • helps to reduce difficulty falling asleep

Warnings

Do not give to children under 12 years of age.

Do not use this product

  • With any other product containing diphenhydramine, even one used on skin.

Ask a doctor before use if you have

  • emphysema
  • chronic bronchitis
  • glaucoma
  • difficulty in urination due to an enlargement of the prostate gland

Ask 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 for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years and over: take 2 tablets at bedtime or as directed by a doctor. For best results, take recommended dose. This will provide approximately 6 to 8 hours of restful sleep.

Other information

  • each tablet contains: calcium 65 mg
  • Store at controlled room temperature 15°-30°C (59°-86°F)
  • avoid excessive heat and humidity
  • *this product is not manufactured or distributed by Glaxosmithkline, owner of the registered trademark Sominex®

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C Blue#1 aluminium lake, magnesium stearate and microcrystalline cellulose.

May also contain: silicon dioxide and stearic acid.

Product Label

*Compare to the active ingredient in Sominex®

Nighttime sleep aid

Diphenhydramine HCl 25mg

wake rested and refreshed

DISTRIBUTED BY:

CHAIN DRUG CONSORTIUM, LLC.

BOCA RATON, FL 33431

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

premier value nighttime sleep aid

Nighttime sleeo aid Diphenhydramine HCl 25 mg

NIGHTTIME SLEEP AID 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-187
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize10mm
FlavorImprint Code 1008;1008
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-187-162 in 1 CARTON07/08/201012/31/2020
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:68016-187-324 in 1 CARTON07/08/201012/31/2020
28 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/08/201012/31/2020
Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 12/2018
 
Chain Drug Consortium, LLC