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

Purpose

Cough suppressant Nasal decongestant

Description

Dextromethorphan HBr 10 mg Phenylephrine HCI 5 mg


Medication Information

Uses

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

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.

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

Description

Dextromethorphan HBr 10 mg Phenylephrine HCI 5 mg

Questions?

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

Section 51945-4

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
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

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.

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

Questions?

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

Section 51945-4 (51945-4)

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
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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