Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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ALLERGY- diphenhydramine hcl 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

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat 

temporarily relieves these symptoms due to the common cold:

  • sneezing
  • runny nose

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor 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

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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 (1-800-222-1222) right away. 

Directions

take every 4 to 6 hours, or as directed by a doctor

do not take more than 6 times in 24 hours

   adults and children 12 years and over: 1 to 2 caplets

   children 6 to under 12 years: 1 caplet

   children under 6 years of age:do not use

Inactive Ingredients

croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Package/Label Principal Display Panel

Diphenhydramine HCl 25mg

Diphenhydramine HCl 25mg

ALLERGY 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69168-048
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)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize12mm
FlavorImprint Code AZ048
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69168-048-932 in 1 BOX12/15/2014
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 69168-048-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/15/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/15/2014
Labeler - Allegiant Health (079501930)

Revised: 11/2018
 
Allegiant Health


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