Active Ingredients (In Each 20 Ml)
Dextromethorphan HBr, USP 30 mg
Doxylamine succinate, USP 12.5 mg
Topcare Tussin Dm Max Solution
FDA Label NDC 36800-788
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Tussin Dm Max (NDC 36800-788). 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 active ingredients (in each 20 ml), purposes, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Cough suppressant
Antihistamine
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- controls the impulse to cough to help you sleep
Do Not Use
- to make a child sleepy
- 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
- trouble urinating due to an enlarged prostate gland
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers
When Using This Product
- do not use more than directed
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop Use And Ask A Doctor If
cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (1-800-222-1222).
Directions
- measure only with dosing cup provided
- keep dosing cup with product
- mL = milliliter
- do not take more than 4 doses in any 24-hour period
- this adult product is not intended for use in children under 12 years of age
age | dose |
adults and children 12 years and over | 20 mL every 6 hours |
children under 12 years | do not use |
Other Information
- each 20 mL contains: sodium 11 mg
- store at 20-25°C (68-77°F)
Inactive Ingredients
anhydrous citric acid, benzoic acid, benzyl alcohol, carboxymethylcellulose sodium, FD&C blue #1, FD&C red #40, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
Questions Or Comments?
1-888-423-0139
Principal Display Panel
COMPARE TO ROBITUSSIN® MAXIMUM STRENGTH NIGHTTIME COUGH DM ACTIVE INGREDIENTS
SEE NEW DOSING
NIGHTTIME
Tussin DM Max
Nighttime Cough DM
COUGH SUPPRESSANT–DEXTROMETHORPHAN HBr
ANTIHISTAMINE–DOXYLAMINE SUCCINATE
MAXIMUM STRENGTH
OUR PHARMACISTS RECOMMEND
RELIEVES:
Cough
Itchy Throat
Runny Nose
Adult
For Ages 12 & Over
4 FL OZ (118 mL)
RASPBERRY, BLACKBERRY & MENTHOL FLAVOR
Tussin Dm Max Image (Image 01)
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