NIGHTTIME SLEEP AID- diphenhydramine hydrochloride tablet 
Chain Drug Marketing Association

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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QCH - 1019- 2019-1004

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

helps to reduce difficulty falling asleep

Warnings

Do not use

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

Ask a doctor before use if you have

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

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

Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C blue #1, magnesium stearate, microcrystalline cellulose

PRINCIPAL DISPLAY PANEL

NDC 63868-611-32

QUALITY CHOICE

†Compare to SOMINEX® active ingredient

Nighttime Sleep Aid

Original Formula

Diphenhydramine HCl, 25mg

Get to sleep safely, wake up refreshed

32 Tablets

image description

NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-611
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 93XF;57344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-611-324 in 1 CARTON06/25/2007
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33806/25/2007
Labeler - Chain Drug Marketing Association (011920774)

Revised: 10/2019
Document Id: 941f59df-2832-37c8-e053-2995a90a7734
Set id: 5fab9bd4-66d7-4356-a778-8900b2e270e2
Version: 3
Effective Time: 20191004
 
Chain Drug Marketing Association