Label: ACTINEL- dextromethorphan hbr,guaifenesin,pseudoephedrine hcl solution
- NDC Code(s): 63102-101-16
- Packager: ACTIPHARMA, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 27, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients (in each 5 mL tsp)
- Purposes
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Uses
• temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold • helps control the cough reflex that causes coughing • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive • temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies (allergic rhinitis).
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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
• heart disease • high blood pressure • thyroid disease • diabetes • 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 emphysemaAsk a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.
When using this product do not use more than directed.
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
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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SPL UNCLASSIFIED SECTION
NEW FORMULA
Contains the same active ingredients as Tusnel®*
SUGAR FREE
DYE FREE
ALCOHOL FREE
SACCHARIN FREECOMMITTED TO HEALTH AND WELL-BEING
WWW.ACTIPHARMA.NETManufactured in USA with imported ingredients for ActiPharma, Inc.
San Juan, PR 00917.* Tusnel® is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.
- Packaging
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INGREDIENTS AND APPEARANCE
ACTINEL
dextromethorphan hbr,guaifenesin,pseudoephedrine hcl solutionProduct 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) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM CITRATE (UNII: EE90ONI6FF) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) 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 Drug M012 09/24/2014 Labeler - ACTIPHARMA, LLC (079340948)