Active Ingredients (In Each 20 Ml)
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Tussin Dm Solution
FDA Label NDC 51316-430
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Woonsocket Prescription Center, Incorporated for the product Tussin Dm (NDC 51316-430). 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), purpose, 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
Purpose
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:
- itching of the nose or throat
- itchy, watery eyes
- runny nose
- sneezing
- controls the impulse to cough to help you sleep
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
- a cough that occurs with too much phlegm (mucus)
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- do not exceed recommended dosage
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop Use And Ask A Doctor If
cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. 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.
Directions
- do not take more than directed
- do not take more than 4 doses in any 24-hour period
- mL = milliliter
- only use the dose cup provided
- adults and children 12 years and over: 20 mL in dosing cup provided every 6 hours
- children under 12 years: do not use
Other Information
- each 20 mL contains: sodium 14 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sugar, xanthan gum
Questions Or Comments?
1-800-426-9391
Principal Display Panel
♥CVS
Health®
Compare to the active
ingredients in Robitussin®
Maximum Strength
Nighttime Cough DM*
MAXIMUM
STRENGTH
MAXIMUM STRENGTH
Nighttime
Tussin DM
DEXTROMETHORPHAN HBr
Cough suppressant
DOXYLAMINE SUCCINATE
Antihistamine
Cough &
Antihistamine
Relieves:
• Cough
• Runny nose
• Sneezing
Menthol-Berry Flavor
For Ages
12 & Over
Dosage cup
provided
Actual Bottle Size
on Side Panel
*This product is not manufactured or distributed by
GlaxoSmithKline Consumer Healthcare Holdings (US)
LLC, owner of the registered trademark Robitussin®
Maximum Strength Nighttime Cough DM.
50844 ORG012304336
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
TAMPER EVIDENT: DO NOT USE IF PRINTED NECK
WRAP IS BROKEN OR MISSING
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2023 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-19849
CVS.com/returnpolicy
100% money back
guaranteed.
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Package Contains One Bottle
Actual Size
Cvs 44-043 (Cvs 44 043 1)
* Please review the disclaimer below.
