Otc - Active Ingredient
Active ingredients
(in each 20 mL)
Dextromethorphan HBr 20 mg
Triprolidine HCl 2.5 mg
Mucinex Fastmax Nighttime Dm Max Solution
FDA Label NDC 72854-141
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rb Health (us) Llc for the product Mucinex Fastmax Nighttime Dm Max (NDC 72854-141). 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.
Label Section Quick Index
Otc - Purpose
Purpose:
Dextromethorphan HBr 20 mg..........Cough suppressant
Triprolidine HCl 2.5 mg...............................Antihistamine
Indications & Usage
Uses
■ 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
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.
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.
Otc - Keep Out Of Reach Of Children
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.
Dosage & Administration
Directions
■ 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
Other Safety Information
Other information
■ each 20 mL contains:
sodium12 mg
■ store at 20-25°C (68-77°F)
■ do not refrigerate
Inactive Ingredient
Inactive ingredients
ammonium glycyrrhizate, anhydrous citric acid,
carmine, edetate disodium, flavor, glycerin (soy),
maltodextrin, propylene glycol, purified water,
sodium benzoate, sorbitol, sucralose, xanthan gum
Otc - Questions
Questions?
1-866-MUCINEX (1-866-682-4639)
Package Label.Principal Display Panel
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