BRONCOMIEL ADULTS- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

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Active ingredients & Purposes

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Active ingredients (in each 10 mL) Purposes

Dextromethorphan HBr 20 mg....................Cough suppressant

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

Phenylephrine HCI 10 mg.........................Nasal decongestant

Uses

Temporarily relieves common cold symptoms:

• stuffy nose
• nasal congestion
• cough due to minor throat and bronchial irritation
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

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Do not use

• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 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.

Ask a doctor before use if you have

• heart disease high blood pressure
• thyroid disease
• diabetes
• a cough that is accompanied by excessive phlegm (mucus)
• a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to an enlarged prostate gland

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breastfeeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• dosage cup included
• do not exceed 6 doses in 24 hours

• Age: Dose
• adults and children 12 years and older: take 10mL every 4 hours
• children under 12 years: consult a doctor

Other information

• each 10 mL contains: sodium 6 mg
• store between 68-77°F (20-25°C)

Inactive ingredients

anhydrous citric acid, FD&C yellow #6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions?

+1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com

Dist by/ por:

PHARMADEL LLC

New Castle, DE 19720

Principal Display Panel

INGREDIENTS AND APPEARANCE

BRONCOMIEL  ADULTS
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-512
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
HONEY (UNII: Y9H1V576FH)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	yellow (Amber to yellow)	Score
Shape		Size
Flavor	HONEY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-512-08	1 in 1 CARTON	07/01/2026
1		240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/01/2016

Labeler - Pharmadel LLC (030129680)