drug facts

drug facts
SPL v3
SPL
SPL Set ID e0a62fa1-9f8a-4770-b28b-1f4f02a762e0
Route
oral
Published
Effective Date 2025-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (20 mg) guaifenesin (400 mg) phenylephrine (10 mg)
Inactive Ingredients
anhydrous citric acid edetate disodium fd&c blue no. 1 fd&c red no. 40 glycerin propyl gallate propylene glycol water sodium benzoate trisodium citrate dihydrate sorbitol sucralose xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2021-05-28 Until 2027-05-28

Purpose

Cough suppressant Expectorant Nasal decongestant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 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 you get to sleep
    • nasal congestion due to a cold
Purpose

Cough suppressant Expectorant Nasal decongestant

Directions
  • do not take more than 6 doses in a 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
  • adults and children 12 years of age 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 17 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients

citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Principal Display Panel

*Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough

Maximum Strength

Mucus Relief

DEXTROMETHORPHAN HBr 20 mg

Cough Suppressant

GUAIFENESIN 400 mg

Expectorant

PHENYLEPHRINE HCl 10 mg

Nasal Decongestant

SEVERE CONGESTION & COUGH

Multi-Symptom Relief

  • Controls Cough
  • Relieves Nasal & Chest Congestion
  • Thin & Loosen Mucus

FOR AGES 12 YEARS AND OVER

FL OZ (mL)

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

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough.

PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC

MATTHEWS, NC 28105

Purposes

Cough suppressant

Expectorant

Nasal decongestant

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
Package Label
HARRIS TEETER Maximum Strength Mucus Relief Severe Congestion & Cough
Questions Or Comments?

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

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 fever, rash or headache that lasts.

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) right away.

Active Ingredients (in Each 20 Ml)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

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)

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 you get to sleep
    • nasal congestion due to a cold
Directions
  • do not take more than 6 doses in a 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
  • adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use
Other Information (Other information)
  • each 20 mL contains: sodium 17 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Principal Display Panel

*Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough

Maximum Strength

Mucus Relief

DEXTROMETHORPHAN HBr 20 mg

Cough Suppressant

GUAIFENESIN 400 mg

Expectorant

PHENYLEPHRINE HCl 10 mg

Nasal Decongestant

SEVERE CONGESTION & COUGH

Multi-Symptom Relief

  • Controls Cough
  • Relieves Nasal & Chest Congestion
  • Thin & Loosen Mucus

FOR AGES 12 YEARS AND OVER

FL OZ (mL)

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

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough.

PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC

MATTHEWS, NC 28105

Purposes

Cough suppressant

Expectorant

Nasal decongestant

Do Not Use (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
Package Label
HARRIS TEETER Maximum Strength Mucus Relief Severe Congestion & Cough
Questions Or Comments? (Questions or comments?)

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

When Using This Product (When using this product)

do not use more than directed.

Stop Use and Ask A Doctor If (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 fever, rash or headache that lasts.

These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 20 Ml) (Active ingredients (in each 20 mL))

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (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)

Advanced Ingredient Data


Raw Label Data

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