ALLERGY SOFTGEL- diphenhydramine hcl capsule, liquid filled 
Allegiant Health

----------

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:
  • runny nose
  • sneezing

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
  • do not take more than 6 doses in 24 hours

Adults and children 12 years and over: 1 to 2 softgels

Children 6 to under 12 years: 1 softgel

Children under 6 years: Do not use

Inactive Ingredients

gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol.

Package/Label Principal Display Panel

Diphenhydramine HCl 25mg

Diphenhydramine HCl 25mg

ALLERGY  SOFTGEL
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-346
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
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColoryellowScoreno score
ShapeCAPSULESize12mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-346-861 in 1 CARTON12/15/201408/31/2021
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01212/15/201408/31/2021
Labeler - Allegiant Health (079501930)

Revised: 11/2018
Document Id: 0bdad4a8-57b6-4aec-ba02-25b7c0fe1b41
Set id: 3eab9688-5054-4280-b88c-fcf9de26a0d2
Version: 5
Effective Time: 20181107
 
Allegiant Health