FDA Label for Dometuss-dm
View Indications, Usage & Precautions
Dometuss-dm Product Label
The following document was submitted to the FDA by the labeler of this product Domel Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Factsactive Ingredients (In Each 5 Ml Tsp)
Guaifenesin 200mg
Dextromethorphan HBr 30 mg
Purpose
Expectorant
Cough suppressant
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily relieves coughs due to minor throat and bronchial irritation as may occur with a cold.
Warnings
- Do not exceed recommended dosage.
- A persistant cough may be a sign of a serious condition; if cough persists for more than one week, tend to recur, or is accompanied by fever, rash, or persistant headache, consult a doctor.
Do Not Use This Product
- for persistant or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
- If you are now taking a prescription Monoaminooxidase 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 you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.
If Pregnant Or Breast-Feeding
as a health professional before use.
Directions
Do not exceed more than 4 doses in any 24- hour period, or as directed by a physician.
| Adults and children 12 years of age and over | Take 1 teaspoonful (5 mL) every 6 hours |
| Children 6 to under 12 years of age | Take 1/2 teaspoonful (2.5 mL) every 6 hours |
| Children under 6 years of age | Ask a doctor |
Other Information
• store at room temperature 15°-30°C (59°-86°F).
Tamper Evident: Do not use if there is evidence of tampering.
Inactive Ingredients
Artificial grape flavor, citric acid, D&C red #33, FD&C blue #1, glycerin, methyl paraben (as preserative), propylene glycol, propyl paraben (as preseratie, purified water, sodium citrate, sucralose.
Questions Or Comments?
Please call (787) 767-3246
Dometuss-Dm Product Label
NDC 53809-201-01
DOMETUSS-DM
EXPECTORANT/COUGH SUPPRESSANT
Alcohol and Sugar
FREE
Grape Flavoe
1 Fl. Oz.
Rev: 10/13
Lot#:/EXP.DATE:
Manufactured for:
DOMEL
SAN JUAN, PUERTO RICO 00924
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