H E B Max Severe Congestion And Cough Liquid
FDA Label NDC 37808-317

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product H E B Max Severe Congestion And Cough (NDC 37808-317). 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, purpose, keep out of reach of children, 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,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Drug Facts

Active ingredients  (in each 20 mL)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCL 10 mg

Purpose

Cough suppressant
Expectorant
Nasal Decongestant

Keep Out Of Reach Of Children

Keep out of reach of children.

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

Warnings 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.
    • for children under 12 years of age

Ask A Doctor Before Use If You Have

  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • 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 are accompanied by a fever
  • cough 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.

Directions

Age - Adults and children 12 years and older       Dose - 20 mL every 4 hours

Age - Children under 12 years of age                  Dose - Do not use

    take only as recommended
    use dosage cup
    mL = milliliter
    do not take more than 6 doses in any 24-hour period

Other Information

  • each 20 mL contains: sodium 10 mg
  • dosage cup provided
  • store between 15-30° C (59-86° F)
  • do not refrigerate

Inactive Ingredients

anhydrous citric acid, edetate disodium, FD and C Blue  #1, FD and C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, Xanthan gum

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Uses

    helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    temporarily relieves these symptoms occurring with a cold:
        cough due to minor throat and bronchial irritation
        nasal congestion

Product Label

Compare to MUCINEX® FAST-MAX™, Severe Congestion and Cough active ingredients*

NDC 37808-317-25

H-E-B®

MAX SEVERE CONGESTION AND COUGH

Maximum Strength

Dextromethorophan HBr
(Cough Suppressant)

Guaifenesin
(Expectorant)

Phenylephrine HCL
(Nasal Decongestant)

Controls Cough
Thins and Loosens Mucus
Relieves Nasal and Chest Congestion

6 FL OZ (177mL)

Adults
For Ages 12 and Over

*This product is not manufactures or distributed bt Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAX™ Severe Congestion and Cough.

MADE WITH PRIDE AND CARE FOR H-E-B, SAN ANTONIO, TEXAS, 782044

GUARANTEE

We believe the high quality of the H-E-B product makes an outstanding value. We hope you'll agree. If not, we'll cheerfully refund your money. Thanks for shopping with us.

Peel Corner to Read Complete Drug Facts and Information

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING



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