Broncofin

Broncofin
SPL v7
SPL
SPL Set ID fdf67382-1692-485b-92f1-2cbb8be4fb70
Route
ORAL
Published
Effective Date 2022-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Glycerin Menthol Methylparaben Propylene Glycol Propylparaben Water Sucrose

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-02-21

Description

Dextromethorphan HBr 10 mg Phenylephrine HCI 5 mg

Purpose

Cough suppressant Nasal decongestant


Medication Information

Purpose

Cough suppressant

Nasal decongestant

Description

Dextromethorphan HBr 10 mg Phenylephrine HCI 5 mg

Uses

Temporarily relieves cough due to minor throat and bronchial irritation and nasal congestion as may occur with the common cold or inhaled irritants

Section 51945-4

Directions

Adults and children 12 years of age and over: take 2 teaspoons (10 mL) every 4 hours. Do not exceed 6 doses in 24 hours.

Children under 12 years of age: consult a doctor.

Do Not Use
  • this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
  • 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
  • if you have heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to enlargement of the prostate gland, unless directed by a doctor
Questions?

call 1-800-560-5223 M-F 9 AM to 4 PM Eastern

Other Information

Store this product between 15°-30°C (59°-86°F)

Inactive Ingredients

cherry flavor, FD&C red #40, FD&C yellow #6, glycerin, menthol, methylparaben, propylene glycol, propylparaben, sucrose, water

Keep Out of Reach of Children.

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

Do Not Exceed Recommended Dosage.

If nervousness, dizziness, or sleepiness occur, discontinue use and consult a doctor. A persistent cough may be a sign of a serious condition. If cough persists more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

If You Are Pregnant Or Breast Feeding

ask a health professional before use.

Active Ingredients (in Each Teaspoonful, (5ml)

Dextromethorphan HBr 10 mg

Phenylephrine HCI 5 mg


Structured Label Content

Uses

Temporarily relieves cough due to minor throat and bronchial irritation and nasal congestion as may occur with the common cold or inhaled irritants

Section 51945-4 (51945-4)

Purpose

Cough suppressant

Nasal decongestant

Directions

Adults and children 12 years of age and over: take 2 teaspoons (10 mL) every 4 hours. Do not exceed 6 doses in 24 hours.

Children under 12 years of age: consult a doctor.

Do Not Use (Do not use)
  • this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
  • 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
  • if you have heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to enlargement of the prostate gland, unless directed by a doctor
Questions?

call 1-800-560-5223 M-F 9 AM to 4 PM Eastern

Other Information (Other information)

Store this product between 15°-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

cherry flavor, FD&C red #40, FD&C yellow #6, glycerin, menthol, methylparaben, propylene glycol, propylparaben, sucrose, water

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Do Not Exceed Recommended Dosage. (Do not exceed recommended dosage.)

If nervousness, dizziness, or sleepiness occur, discontinue use and consult a doctor. A persistent cough may be a sign of a serious condition. If cough persists more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

If You Are Pregnant Or Breast Feeding (If you are pregnant or breast-feeding)

ask a health professional before use.

Active Ingredients (in Each Teaspoonful, (5ml) (Active Ingredients (in each teaspoonful, (5mL))

Dextromethorphan HBr 10 mg

Phenylephrine HCI 5 mg


Advanced Ingredient Data


Raw Label Data

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