FDA Label for Actinel
View Indications, Usage & Precautions
Actinel 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 5Ml Tsp)
Dextromethorphan HBr, 15mg
Guaifenesin, 200 mg
Pseudoephedrine HCl, 30 mg
Purpose
Cough Suppressant
Expectorant
Nasal Decongestant
Uses:
temporarily:
• relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies
• relieves sinus congestion and pressure, help decongest sinus openings and passages
• restores freer breathing through the nose
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make cough more productive
• suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
Warnings:
• A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
• Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.
Do not:
• take this product for persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
• use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s… prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
Stop use and ask a doctor if:
• symptoms do not improve within 7 days or are accompanied by fever
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. Prompt medical attention is critical for adults as well as for children even if you do not notice any sign or symptoms.
Directions:
• Adults and children 12 years of age and over: Take 1 to 2 teaspoonfuls every 6 hours if needed, not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor.
• Children 6-12 years, Take ½ to 1 teaspoonful every 6 hours if needed, do not exceed 4 teaspoonfuls in 24 hours, or as directed by a doctor.
• Children under 6 years of age: consult a doctor
Other Information
• Tamper Evident: Do not use if inner seal is torn, cut, or opened.
• Store at room temperature 15°- 30°C (59° - 86°F)
• Avoid excessive heat or humidity.
Inactive Ingredients:
citric acid, flavor, glycerin, methyl paraben, propylene glycol, propyl paraben, purified water, sodium citrate, sucralose
Other
Manufactured in the USA for ActiPharma, Inc, Dorado, PR 00646- Tel: (787) 608-0882
*Tusnel® is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.
NEW FORMULA
Contains the same active ingredients as Tusnel®*
COUGH SUPPRESSANT
EXPECTORANT
NASAL DECONGESTANT
SUGAR FREE
DYE FREE
ALCOHOL FREE
COST –EFFECTIVE SOLUTIONS
* Please review the disclaimer below.