Cough And Chest Congestion Solution
FDA Label NDC 79481-7500

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer, Inc. for the product Cough And Chest Congestion (NDC 79481-7500). 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 15 ml), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 15 Ml)

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Purpose

Cough suppressant

Expectorant

Uses

  • temporarily relieves common cold symptoms:
    • cough due to minor throat and bronchial irritation
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a sodium-restricted diet

Stop Use And Ask A Doctor If

  • cough persists for more than 7 days, comes back or occurs with a 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 right away (1-800-222-1222).

Directions

  • take only as directed
  • only use the dose cup provided
  • do not exceed 6 doses per 24 hours
    • adults and children 12 years and over30 mL every 4 hourschildren 6 to under 12 years15 mL every 4 hourschildren 4 to under 6 yearsask a doctorchildren under 4 yearsdo not use
     
     
     
     
     
     
     
     

Other Information

  • each 15 mL contains: sodium 15 mg
  • store at 20-25℃ (68-77℉). Do not refrigerate.

Inactive Ingredients

anhydrous citric acid, D&C yellow #10, FD&C green #3, FD&C red #40, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

1-800-719-9260

Package/Label Principal Display Panel

meijer®

Cough & Chest Congestion

Dextromethorphan HBr (Cough Suppressant)

Guaifenesin (Expectorant)

COMPARE TO VICKS® FORMULA 44® DM ACTIVE INGREDIENTS

RELIEVES: COUGH, CHEST CONGESTION

THINS & LOOSENS MUCUS

HONEY FLAVOR

12 FL OZ (355 mL)

Meijer-cough-&-chest-congestion-container-image.jpg (Image 01)

Meijer-cough-&-chest-congestion-container-image.jpg (Image 01)

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