PEDIAVENT- dexbrompheniramine maleate syrup 
CarWin Pharmaceutical Associates, 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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PediaVent™ Syrup

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Dexbrompheniramine Maleate 2 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

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

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor before use if you are taking sedatives or tranquilizers

When using this product

  • excitability may occur, especially in children
  • may cause drowsiness
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • new symptoms occur

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

Keep out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not exceed recommended dosage.

AGEDOSE
Adults and Children 12 years of age and older:1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls (30 mL) in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age½ teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls (15 mL) in 24 hours, or as directed by a doctor
Children under 6 years of ageConsult a doctor

Other information

Store at 15°-30° C (59°-86° F).

Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken.

Inactive ingredients

grape flavor, citric acid, glycerin, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sucralose, sorbitol.

Questions? Comments?

Call 1-866-633-9033.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 15370-110-04

Antihistamine
PediaVent™
SYRUP

Each teaspoonful (5 mL) contains:
Dexbrompheniramine Maleate      2 mg

Sugar-Free • Dye Free
Alcohol Free

Grape Flavor

CW
CARWIN
PHARMACEUTICAL
ASSOCIATES, LLC

4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
PEDIAVENT 
dexbrompheniramine maleate syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15370-110
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE2 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15370-110-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/201406/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/04/201406/06/2023
Labeler - CarWin Pharmaceutical Associates, LLC (079217215)

Revised: 6/2023
Document Id: 429aa9e6-5012-46c2-8450-f4ce6b259803
Set id: 16687961-4660-4233-9a90-5637fae1c4da
Version: 2
Effective Time: 20230607
 
CarWin Pharmaceutical Associates, LLC