Active Ingredient
(in each 3 mL) (one dose) Dextromethrophan HBr, 30 mg
Robocough Liquid
FDA Label NDC 71598-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dxm Pharmacuetical, Inc. for the product Robocough (NDC 71598-102). 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 ingredient, purpose, uses, warning, dosage & administration, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough suppressant
Uses
- Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.
Warning
Do not useif 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 is accompanied by excessive phlegm (mucus), or
• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema.
Stop use and ask a doctor ifa cough persists for more than 1 week, tends to recur, 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)
Dosage & Administration
Directions
• do not exceed 120 milligrams (4 doses) in any 24-hour period
• measure only 3 mL with dosing syringe provided
• only use this product according to these directions
age dose
adults and children 12 years and over
3mL every 6 to 8 hours
children under 12 years
do not use
Other Information
•
TAMPER EVIDENT: Do not use if seal on the bottle is broken.
• store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
Citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, stevia, sucralose, sucrose
Questions Or Comments?
833-289-7626 between 10 a.m. to 4 p.m. CST, Monday-Friday
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