Mucus Relief Severe Congestion And Cough
FDA Label NDC 46122-219

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Good Neighbor Pharmacy for the product Mucus Relief Severe Congestion And Cough (NDC 46122-219). 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 drug facts, purpose, uses, warnings, do not use, 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

→ Drug Facts

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast Feeding

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel

Drug Facts

Dextromethorphan HBr 20mg

Guaifenesin 400 mg

Phenylephrine HCl 10mg

Purpose

Dextromethorphan............................Cough suppressant

Guaifenesin................................Expectorant

Phenylephrine HCL..........................Nasal Decongestant

Uses

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, helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

for children under 12 years of age

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

persistent or chronic cough such as occurs with smoking, astha, chrinic 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

cough lasts more than 7 days, comes back, or occurs with fever, 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 1-800-222-1222 immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not exceed recommended dosage

use dosage cup provided

do not take more than 6 doses in a 24 hour period

do not use dosing cup with other products

dose as follows or as directed by a doctor mL=milliliter

children under 12 years-do not use

adults and children 12 years and older-20mL every 4 hours

Other Information

each 20mL contains potassium 6mg, sodium 13mg

store at room temperature

do not refrigerate

Inactive Ingredients

citric acid, dextrose, flavors, glycerin, methyl paraben, potassium sorbate, propylene glycol, propyl paraben, purified water, red 33, red 40, saccharin sodium, sodium hydroxide, sucralose, xanthan gum