Otc - Active Ingredient
Active ingredients (in each 20 mL)
Day:
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Night:
Dextromethorphan HBr 20 mg
Triprolidine HCl 2.5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Fast-max Dm Max And Mucinex Fast-max Nighttime Dm Max Value Pack (NDC 72854-142). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each 20 mL)
Day:
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Night:
Dextromethorphan HBr 20 mg
Triprolidine HCl 2.5 mg
Purposes
Day:
Dextromethorphan HBr 20 mg.....................................Cough suppressant
Guaifenesin 400 mg........................................................Expectorant
Night:
Dextromethorphan HBr 20 mg...............................................Cough suppressant
Triprolidine HCl 2.5 mg....................................................................Antihistamine
Uses
Day:
■ 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
Night:
■ 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
■ runny nose
■ sneezing
■ itching of the nose or throat
■ itchy, watery eyes due to hay fever
Warnings
Day:
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
■ 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
■ 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.
Night:
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
■ glaucoma
■ trouble urinating due to an enlarged prostate gland
■ a breathing problem such as emphysema or chronic bronchitis
■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema
■ cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
■ do not use more than directed
■ excitability may occur, especially in children
■ marked drowsiness may occur
■ alcohol, sedatives, and tranquilizers may increase drowsiness
■ avoid alcoholic drinks
■ use caution when driving a motor vehicle or operating machinery
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.
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.
Directions
Day:
■ do not take more than 6 doses in any 24-hour period
■ measure only with dosing cup provided
■ do not use dosing cup with other products
■ dose as follows or as directed by a doctor
■ adults and children 12 years of age and over: 20 mL in dosing cup provided every
4 hours
■ children under 12 years of age: do not use
Night:
■ do not take more than 4 doses in any 24-hour period
■ measure only with dosing cup provided
■ do not use dosing cup with other products
■ dose as follows or as directed by a doctor
■ adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
■ children under 12 years of age: do not use
Day/Night:
■ each 20 mL contains: sodium 12 mg
■ store at 20-25°C (68-77°F)
■ do not refrigerate
Inactive ingredients
Day:
ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C red no. 40,
flavor, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate,
sorbitol, sucralose, trisodium citrate dihydrate*, xanthan gum
*may contain this ingredient
Night:
ammonium glycyrrhizate, anhydrous citric acid,
carmine, edetate disodium, flavor, glycerin
(soy),maltodextrin, propylene glycol,
purified water, sodium benzoate, sorbitol,
sucralose, xanthan gum
Questions? 1-866-MUCINEX
(1-866-682-4639)
* Please review the disclaimer below.