NIGHTTIME SLEEP AID- diphenhydramine hydrochloride tablet, coated 
VALU MERCHANDISERS COMPANY

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.

----------

1091-BST-2021-1116

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

for relief of occasional sleeplessness

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product avoid alcoholic drinks

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

Directions

adults and children 12 years of age and overtake 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years of agedo not use

Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C blue #1, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE INGREDIENT IN SIMPLY SLEEP®†

Best Choice®

NIGHTTIME

Sleep Aid

Siphenhydramine HCl

For a Restful Night's Sleep

Non Habit-Forming

Contains No Pain Reliever

24 CAPLETS 25 mg EACH

image description

NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-091
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize11mm
FlavorImprint Code 25;052
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63941-091-014 in 1 CARTON02/25/2010
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33802/25/2010
Labeler - VALU MERCHANDISERS COMPANY (868703513)

Revised: 11/2021
Document Id: d11b084f-9db5-db89-e053-2995a90afe4d
Set id: 70ec6ac1-2fd8-49dd-9ccb-c16e2f09a2b2
Version: 2
Effective Time: 20211118
 
VALU MERCHANDISERS COMPANY