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Allergy Softgel by Allegiant Health

Medically reviewed on December 15, 2017

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Allegiant Health
NDC Code: 69168-346

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.

Drug Facts

Active ingredient

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat and these symptoms associated with the common cold: sneezing runny nose

Warnings

Do not usewith any other products containing diphenhydramine, including one applied topically

Ask a doctor if you have

a breathing problem such as emphysema or chronic bronchitis, glaucoma or 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 beverages alcohol, sedatives, and tranquilizers may increase drowsiness be careful when drivinga 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 accidental overdose, contact a doctor or Poison Control Center immediately

Directions

take every 4 to 6 hours do not take more than 6 doses in 24 hours
Adults and children 12 years of age and older: 25 mg to 50 mg (1 to 2 softgels)
Children 6 to under 12 years of age: 25 mg (1 softgel)
Children under 6 years of age: Do not use

Inactive Ingredients

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

Package/Label Principal Display Panel
ALLERGY  SOFTGEL
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-346
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize12mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69168-346-8612 CAPSULE, LIQUID FILLED in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/15/2014
Labeler - Allegiant Health (079501930)
Registrant - Allegiant Health (079501930)
Establishment
NameAddressID/FEIOperations
Allegiant Health079501930ANALYSIS(69168-346), LABEL(69168-346), MANUFACTURE(69168-346), PACK(69168-346), RELABEL(69168-346), REPACK(69168-346)

 
Allegiant Health

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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