PEDIAVENT- dexbrompheniramine maleate syrup

PediaVent by

Drug Labeling and Warnings

PediaVent by is a Otc medication manufactured, distributed, or labeled by CarWin Pharmaceutical Associates, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

AGE	DOSE
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 age	½ 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 age	Consult 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)

INGREDIENTS AND APPEARANCE

PEDIAVENT 
dexbrompheniramine maleate syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15370-110
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	2 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15370-110-04	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/04/2014

Labeler - CarWin Pharmaceutical Associates, LLC (079217215)