SELECT HEALTH ALLERGY RELIEF  CHERRY- diphenhydramine hydrochloride liquid 
Axcentria Pharmaceuticals, LLC.

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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Children's
ALLERGY
RELIEF

Drug Facts

Active ingredient (in each 5 mL tsp)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

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

Warnings

Do not use

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

Ask a doctor before use

  • if the child has a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

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

Directions

Other Information

Inactive Ingredients

anhydrous citric acid, D&C res #33, FD&C red #40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions?

Adverse drug event call (888) 933-3222

PRINCIPAL DISPLAY PANEL - 118 ML Bottle Carton

Children's
ALLERGY
RELIEF

HealthSelect®

Diphenhydramine HCl
Antihistamine

For Temporary Relief of:

For Ages 12 and Older
Alcohol Free

NET 4 FL OZ
(118 ML)

NDC 49743-3001-1

Principal Display Panel
SELECT HEALTH ALLERGY RELIEF   CHERRY
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49743-3003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Glycerin (UNII: PDC6A3C0OX)  
polyethylene glycols (UNII: 3WJQ0SDW1A)  
sodium citrate (UNII: 1Q73Q2JULR)  
sodium chloride (UNII: 451W47IQ8X)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49743-3003-1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/01/2011
Labeler - Axcentria Pharmaceuticals, LLC. (961871501)
Establishment
NameAddressID/FEIBusiness Operations
Axcentria Pharmaceuticals, LLC.961871501MANUFACTURE

Revised: 8/2011
Document Id: dfcebe7c-7215-47cf-9e2c-9822439eb207
Set id: 04e38dab-16b1-4848-9dcb-92e9f67e6119
Version: 1
Effective Time: 20110826
 
Axcentria Pharmaceuticals, LLC.