Active Ingredients (In Each 5 Ml)
Dextromethorphan HBr 10 mg
Guaifenesin 100 mg
Diabetic Tussin Dm
FDA Label NDC 68151-0062
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Carilion Materials Management for the product Diabetic Tussin Dm (NDC 68151-0062). 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 5 ml), purposes, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Cough Suppressant
Expectorant
Uses
- temporarily relieves cough
- helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus
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 two 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)
- a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
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
- take every 4 hours
- do not exceed 6 doses in 24 hours
| adults & children 12 years & over | 10 mL (2 teaspoonfuls) |
| children 6 years to under 12 years | 5 mL (1 teaspoonful) |
| children 2 years to under 6 years | 2.5 mL (½ teaspoonful) |
| children under 2 years | ask a doctor |
Other Information
Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
Storage
- store at room temperature 20-25°C (68-77°F)
- keep tightly closed
Inactive Ingredients
Acesulfame potassium, artificial cherry flavor, artificial vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.
Questions And Comments?
Call 1-800-899-3116, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST.
Serious side effects associated with use of this product may be reported to this number.
How Supplied
Product: 68151-0062
NDC: 68151-0062-1 5 mL in a CUP, UNIT-DOSE
* Please review the disclaimer below.
