Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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SLEEP AID- diphenhydramine hcl 25 mg tablet 
Allegiant Health

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 caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep aid

Uses

relief of occasional sleeplessness

Warnings

Do not use

  • in children under 12 years of age
  • with any other products containing diphenhydramine, including ones used on skin 

Ask 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 Doctor or Pharmacist before use if you

are taking sedatives or tranquilizers

When using this product

  • avoid alcoholic beverages
  • drowsiness may occur
  • do not drive 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 a serious underlying medical illness.

If pregnancy or breast-feeding

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

Keep Out of Reach of Children

Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. 

Directions

adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor

children under 12 years of age: do not use

Other information

  • store at room temperature store between 20-25°C (68-77°F)
  • do not use if blister unit is torn or open

Inactive Ingredients

croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Package/Label Principal Display Panel

 Sleep Aid

Sleep Aid

SLEEP AID 
diphenhydramine hcl 25 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69168-263
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize12mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69168-263-3030 in 1 BOTTLE; Type 0: Not a Combination Product03/03/2015
2NDC: 69168-263-9324 in 1 BOX; Type 0: Not a Combination Product03/03/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33803/03/2015
Labeler - Allegiant Health (079501930)

Revised: 12/2018
 
Allegiant Health


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