FDA Label for Actinel Diabetic
View Indications, Usage & Precautions
Actinel Diabetic Product Label
The following document was submitted to the FDA by the labeler of this product Actipharma, Llc. 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 Facts
Active Ingredients (In Each 5 Ml Teaspoonful)
Dextromethorphan HBr 10 mg
Guaifenesin 100 mg
Purposes
Cough suppressant
Expectorant
Uses
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily relieves cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
Warnings
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
• cough is accompanied by excessive phlegm (mucus)
• persistent or chronic cough such occurs with smoking, asthma, or emphysema
When using this product
• do not exceed recommended dosage
Stop use and ask a doctor if
• cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or a persistent headache, These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
• do not exceed 6 doses in any 24-hour period.
• mL = milliliter, tsp = teaspoon
| adults and children 12 years of age and over | 10 mL (2 tsp) every 4 hours |
| children under 12 years of age | consult a doctor |
Other Information
• tamper evident feature: Do not use if inner seal is torn, cut, or opened
• store at controlled room temperature 15° - 30°C (59° - 86°F)
• avoid excessive heat or humidity
Inactive Ingredients
citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
Questions Or Comments?
1.787.608.0082
You may also report serious side effects to this phone number.
Call weekdays from 8AM to 4PM AST
Packaging
* Please review the disclaimer below.
