Label: ACTINEL- dextromethorphan hbr,guaifenesin,pseudoephedrine hcl solution
- NDC Code(s): 63102-101-16
- Packager: Actipharma, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated December 3, 2018
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- Drug Facts
- Active Ingredients (in each 5mL tsp)
• 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 coughs more productive
• suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
• 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.
• 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 conditions, 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.
• 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
- Inactive ingredients:
SPL UNCLASSIFIED SECTION
Contains the same active ingredients as Tusnel®*
COST –EFFECTIVE SOLUTIONS
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.
INGREDIENTS AND APPEARANCE
dextromethorphan hbr,guaifenesin,pseudoephedrine hcl solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63102-101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 5 mL PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63102-101-16 474 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/24/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/24/2014 Labeler - Actipharma, Inc (079340948)