Adult Severe Congestion And Cough
FDA Label NDC 49348-083

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Adult Severe Congestion And Cough (NDC 49348-083). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each 20 ml), purpose, uses, otc - keep out of reach of children, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients (in Each 20 Ml)

→ Purpose

→ Uses

→ Otc - Keep Out Of Reach Of Children

→ Warnings

→ Ask A Doctor Before Use If You Have

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel

Active Ingredients (In Each 20 Ml)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Uses

hepls loosen phelgm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
temporarily relieves:
cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
the intensity of coughing
the impulse to cough to help you get to sleep
nasal congestion due to a cold

Otc - Keep Out Of Reach Of Children

Warnings

Do not use

for children under 12 years of age
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
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
cough that occurs with too much phlegm (mucus)

When Using This Product

do not use more than directed

Stop Use And Ask A Doctor If

nervousness, dizziness or sleeplessness occur
symptoms do not get better within 7 days or occur with fever
cough comes back, or occurs with rash or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

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

do not take more than 6 doses in 24-hour period
measure only with dosing coup provided
do not use dosing cup with other products
dose as follows or as directed by a doctor
Adults and children 12 years and older: 20 mL in dosing cup provided every 4 hours
Children under 12 years of age: Do not use

Other Information

each 20 mL contains: sodium 20 mg
store between 15-30^oC(59-86^oF)
do not refrigerate
dosing cup provided

Inactive Ingredients

citric acid anhydrous, edetate disodium, FDand C blue 1, FD and C red 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum