drug facts

drug facts
SPL v5
SPL
SPL Set ID 1bf9a59e-cc37-4780-ba75-7138c546eb19
Route
oral
Published
Effective Date 2024-06-06
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 sodium citrate sorbitol sucralose xanthan gum

Identifiers & Packaging

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

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 irritant
    • 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 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
  • adult and children 12 years of age and older: 20 mL in dosing cup provided avery 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 active ingredients in Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough*

maximum strength

fast mucus relief severe congestion and cough

dextromethorphan HBr 20 mg (cough suppressant)

guaifenesin 400 mg (expectorant)

phenylephrine HCI 10 mg (nasal decongestant)

controls cough

relieves nasal and chest congestion

thins and loosens mucus

AGES 12 + YEARS

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

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

Dist. by Target Corp.

Minneapolis, MN 55403

Purposes

Cough suppressant

Expectorant

Nasal decongestant

Do Not Use
  • if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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
Product Label
TARGET Maximum Strength Mucus Relief Severe Congestion and Cough
Questions Or Comments?

Call 1-800-910-6874 

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.

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, emphysema
  • cough that occurs with too much phlegm (mucus)
Active Ingredients  (in Each 20 Ml)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg


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 irritant
    • 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 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
  • adult and children 12 years of age and older: 20 mL in dosing cup provided avery 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 active ingredients in Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough*

maximum strength

fast mucus relief severe congestion and cough

dextromethorphan HBr 20 mg (cough suppressant)

guaifenesin 400 mg (expectorant)

phenylephrine HCI 10 mg (nasal decongestant)

controls cough

relieves nasal and chest congestion

thins and loosens mucus

AGES 12 + YEARS

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

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

Dist. by Target Corp.

Minneapolis, MN 55403

Purposes

Cough suppressant

Expectorant

Nasal decongestant

Do Not Use (Do not use)
  • if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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
Product Label
TARGET Maximum Strength Mucus Relief Severe Congestion and Cough
Questions Or Comments? (Questions or comments?)

Call 1-800-910-6874 

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.

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, emphysema
  • cough that occurs with too much phlegm (mucus)
Active Ingredients  (in Each 20 Ml) (Active ingredients  (in each 20 mL))

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg


Advanced Ingredient Data


Raw Label Data

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