BRONCOTRON PED- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops

Broncotron PED by

Drug Labeling and Warnings

Broncotron PED by is a Otc medication manufactured, distributed, or labeled by Seyer Pharmatec, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                 Purpose

(in each 1 mL)

Dextromethorphan HBr 5 mg ...... Cough Suppressant

Guaifenesin 100 mg .................... Expectorant

Phenylephrine HCl 2.5 mg ............. Nasal Decongestant

PURPOSE

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

INDICATIONS & USAGE

Uses non-narcotic cough suppressant which temporarily calms cough due to minor throat and bronchial irritation as may occur with the common cold

• calms the cough control center and relieves coughing
• helps decongest sinus openings and passages; temporarily relieves sinus congestions and pressure
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive.
• temporarily relieves nasal congestion due to the common cold

WARNINGS

Warnings

• do not exceed recommended dosage
• a persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.

Ask a doctor before use if a child has

• a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or empgysema, or where cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
• heart disease
• high blood pressure
• thyroid disease
• diabetes

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur
• if symptoms do not improve within 7 days or are accompanied by fever

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

DO NOT USE

Do not use this in a child who is

• taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental overdose, seek professional  help or contact a Poison Control Center immediately.

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

Directions

• take every 4 hours, not to exceed 6 doses in 24 hours or as directed by a physician

• Children 6 to under 12 years of age: 2 mL
• Children 2 to under 6 years of age: Ask a doctor
• Children under 2 years of age: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients

Citric acid, flavor, magnasweet, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose, xanthan gum

QUESTIONS

Questions or comments 1-888-782-3585

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRONCOTRON PED 
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11026-2790
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE (Grape Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11026-2790-2	1 in 1 CARTON
1		60 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/15/2012

Labeler - Seyer Pharmatec, Inc. (832947126)