DIPHENHYDRAMINE HCL 25MG- sleep aid tablet, coated 
Allegiant Health

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GreenField - Sleep Aid

Active ingredient(s)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep aid

Use(s)

for relief of occasional sleeplessness

Warnings

Do not use

  • In children under 12 years of age
  • With any other product containing diphenydramine, even one used on skin

Ask a doctor before use if

  • 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 beverages
  • drowsiness will occur
  • do not drive a motor vehicle or operate 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.

Pregnancy/Breastfeeding

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

Keep out of reach of children

In case of accidental overdose, contact a doctor or Poison Control Center 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

Inactive ingredients

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

Principal Display Panel

Sleep Aid

Sleep Aid


DIPHENHYDRAMINE HCL 25MG 
sleep aid tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-002
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)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize12mm
FlavorImprint Code 263;arch
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-002-9324 in 1 CARTON; Type 0: Not a Combination Product11/23/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01011/23/2021
Labeler - Allegiant Health (079501930)

Revised: 11/2021
Document Id: 36c028e5-005a-42eb-958c-9fed406827b3
Set id: 2890e4ba-d642-437d-8a86-24996a74e027
Version: 4
Effective Time: 20211123
 
Allegiant Health