PEDIAVENT- dexbrompheniramine maleate tablet, chewable

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 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.

AGE	DOSE
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 age	1 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 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.

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

INGREDIENTS AND APPEARANCE

PEDIAVENT 
dexbrompheniramine maleate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15370-112
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	1 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	16mm
Flavor	BERRY	Imprint Code	112
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15370-112-60	60 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/05/2014

Labeler - CarWin Pharmaceutical Associates, LLC (079217215)