BRONCOTRON D- guaifenesin, dextromethorphan, phenyphrine hydrchloride liquid

Broncotron by

Drug Labeling and Warnings

Broncotron by is a Otc medication manufactured, distributed, or labeled by SEYER PHARMATEC, INC., Lex Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients  (in each 5 mL teaspoonful)................................Purpose


Guaifenesin 200 mg........................................................................... Expectorant

Dextromethorphan HBr 20 mg............................................................ Cough Suppressant

Phenylephrine HCL 5 mg.................................................................. Nasal Decongestant

PURPOSE

Uses

• Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
• Temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold.
• Temporarily relieves nasal congestions due to the common cold.

WARNINGS

Warnings

Ask the doctor before if you have:

• heart disease
• high blood pressure
• thyroid
• diabetes
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

When using this product:

• do not exceed recommended dosage.

Stop use and ask a doctor if:

• your child gets nervous, dizzy, or sleepless.
• condition lasts for more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

DO NOT USE

Do not use

if you are now taking a prescription monoamine pxidase inhibitor (MAOI), (certain drugs for depression, psychiatric, or emotional conditions, or Parkison's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your description drug contains an MAOI, ask a doctor or pharmacist before taking this product.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health care professional before use.

DOSAGE & ADMINISTRATION

Directions: SHAKE WELL BEFORE USE

•      do not take more than 3 doses in any 24 hour period

• Age: Dose
• adults and children 12 years and over: take 2 teaspoonfuls every 8 hours
• children 6 years to under 12 years: 1 teaspoonful every 8 hours
• children 2 years to under 6 years: 1/2 teaspoonful every 8 hours
• children under 2 years: do not use

INDICATIONS & USAGE

Other Information:

• Warning: Phenylketonurics: Contains phenylalanine 15 mg per 5 mL
• Store at 15-30 degree celsius(59-86 degree farenheit)
• Alcohol Free and Phenylpropanolamine(PPA) Free

INACTIVE INGREDIENT

Inactive Ingredients:

Aspartame, cherry flavor, citric acid, glycerin, hydroxyethyl cellulose, kaolin, magnesium aluminium silicate, methylparaben, propylparaben, purified water, sodium citrate, sorbitol.

QUESTIONS

Any questions or comments, please call toll-free: 1-888-782-3585

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRONCOTRON  D
guaifenesin, dextromethorphan, phenyphrine hydrchloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11026-2681
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (Cherry Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11026-2681-4	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2007

Labeler - SEYER PHARMATEC, INC. (832947126)

Registrant - SEYER PHARMATEC, INC. (832947126)

Establishment
Name	Address	ID/FEI	Business Operations
Lex Inc.		046172888	manufacture