FDA Label for Actinel Dm
View Indications, Usage & Precautions
Actinel Dm Product Label
The following document was submitted to the FDA by the labeler of this product Actipharma, Inc. 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 Tsp)
Dextromethorphan HBr, USP.....20 mg
Guaifenesin, USP......................400 mg
Phenylephrine HCl, USP............10 mg
Purpose
Cough Suppressant
Expectorant
Nasal Decongestant
Uses
• Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes • Temporarily relieves these symptoms occurring with a cold: • nasal congestion • cough due to minor throat and bronchial irritation.
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 you have • diabetes • heart disease • thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
When using this product • do not exceed recommended dosage
Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days or are accompanied by fever • coughs lasts more than 7 days, come back, 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 accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than 6 doses in any 24-hour period.
| Adults and Children 12 years of age and over | 5mL (1tsp), every 4 hours |
| Children under 12 years of age | ask a doctor |
Other Information
• Store at room temperature 15°- 30°C (59°- 86°F) • protect from freezing • protect from light • Avoid excessive heat or humidity. TAMPER EVIDENT: Do not use if inner seal is torn, broken or missing. Pharmacist: Preserve and dispense in tight, light-resistant container with a child resistant cap as defined in the USP.
Inactive Ingredients:
Artificial and natural flavors, citric acid, glycerin, menthol, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate and sucralose.
Packaging
* Please review the disclaimer below.