drug facts

drug facts
SPL v7
SPL
SPL Set ID 9ba5ca1b-2e3c-439e-8887-c26f144b88ef
Route
oral
Published
Effective Date 2024-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (5 mg) guaifenesin (100 mg)
Inactive Ingredients
anhydrous citric acid d&c red no. 33 dextrose fd&c red no. 40 glycerin methylparaben potassium sorbate propylene glycol propylparaben water saccharin sodium sodium hydroxide sucralose xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-07-31
Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg

Medication Information

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus 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 your child get to sleep
Purpose

Cough suppressant Expectorant

Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL = milliliter
  • shake well before using
age  dose 
 children 6 to under 12 years  5-10 mL every 4 hours 
 children 4 to 5 years  2.5-5 mL every 4 hours
 children under 4 years  do not use


Other Information
  • each 5 mL contains: sodium 2 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients

anhydrous citric acid, D&C red #33, dextrose, FD&C red #40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sucralose, xanthan gum

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg

Principal Display Panel

Compare to Children's Mucinex® Cough active ingredients*

Children's Mucus Relief Cough

Dextromethorphan HBr 5 mg / Cough Suppressant

Guaifenesin 100 mg / Expectorant

Cough Relief

For Ages 4 to 11 Years

Alcohol-Free

Relief of:

  • Cough
  • Chest Congestion
  • Mucus

Cherry Flavor

FL OZ (mL)

**This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Cough.

TAMPER EVIDENT:  DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

MADE WITH PRIDE AND CARE FOR

H-E-B®, SAN ANTONIO, TX 78204

Purposes

Cough suppressant

Expectorant

Do Not Use
  • in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Package Label
H-E-B Children's Mucus Cough Relief
Questions Or Comments?

 Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

Stop Use and Ask A Doctor If

cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredients (in Each 5 Ml)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Ask A Doctor Before Use If the Child Has
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus 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 your child get to sleep
Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL = milliliter
  • shake well before using
age  dose 
 children 6 to under 12 years  5-10 mL every 4 hours 
 children 4 to 5 years  2.5-5 mL every 4 hours
 children under 4 years  do not use


Other Information (Other information)
  • each 5 mL contains: sodium 2 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, D&C red #33, dextrose, FD&C red #40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sucralose, xanthan gum

Principal Display Panel

Compare to Children's Mucinex® Cough active ingredients*

Children's Mucus Relief Cough

Dextromethorphan HBr 5 mg / Cough Suppressant

Guaifenesin 100 mg / Expectorant

Cough Relief

For Ages 4 to 11 Years

Alcohol-Free

Relief of:

  • Cough
  • Chest Congestion
  • Mucus

Cherry Flavor

FL OZ (mL)

**This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Cough.

TAMPER EVIDENT:  DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

MADE WITH PRIDE AND CARE FOR

H-E-B®, SAN ANTONIO, TX 78204

Purposes

Cough suppressant

Expectorant

Do Not Use (Do not use)
  • in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Package Label
H-E-B Children's Mucus Cough Relief
Questions Or Comments? (Questions or comments?)

 Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

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 (1-800-222-1222) right away.

Active Ingredients (in Each 5 Ml) (Active ingredients (in each 5 mL))

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:56.942233 · Updated: 2026-03-14T23:02:46.668637