PEDIAVENT- dexbrompheniramine maleate tablet, chewable 
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™ Chewable Tablets

Drug Facts

Active ingredients (in each tablet)

Dexbrompheniramine Maleate 1 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:2 tablets every 4 to 6 hours, not to exceed 12 tablets in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age1 tablet every 4 to 6 hours, not to exceed 6 tablets 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.

Dispense in a tight, light-resistant container with a child-resistant cap.

Inactive ingredients

berry flavor, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, stearic acid, sucralose, and xylitol.

Questions? Comments?

Call 1-866-633-9033.

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

NDC 15370-112-60

Antihistamine

PediaVent™
CHEWABLE TABLETS

Each chewable tablet contains:
Dexbrompheniramine Maleate 1 mg

Berry Flavored

CARWIN
PHARMACEUTICAL
ASSOCIATES, LLC

60 Tablets

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label
PEDIAVENT 
dexbrompheniramine maleate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15370-112
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE1 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize16mm
FlavorBERRYImprint Code 112
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15370-112-6060 in 1 BOTTLE; Type 0: Not a Combination Product08/05/201406/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/05/201406/06/2023
Labeler - CarWin Pharmaceutical Associates, LLC (079217215)

Revised: 6/2023
Document Id: 24be6011-9b83-451a-89a9-5d9318656266
Set id: f0b90cc2-901c-4498-b892-d8883182b6fd
Version: 2
Effective Time: 20230607
 
CarWin Pharmaceutical Associates, LLC