Label: ACTIDOM DMX- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution
- NDC Code(s): 63102-110-16
- Packager: ACTIPHARMA, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 28, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (in each 5 mL tsp)
- Purposes
- Uses
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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 emphysema.
Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.
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, comes 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.
- Directions
- Other information
- Inactive ingredients
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SPL UNCLASSIFIED SECTION
Contains the same active ingredients as Dometuss®-DMX*
SUGAR FREE
ALCOHOL FREE
Grape Flavor
Manufactured in USA with imported ingredients for ActiPharma. San Juan, PR 00917. www.actipharma.net.
* Dometuss® DMX is a registered trademark of Domel Laboratories. This product is not manufactured, distributed or marketed by Domel Laboratories.
- Packaging
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INGREDIENTS AND APPEARANCE
ACTIDOM DMX
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63102-110 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 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 purple (Clear) Score Shape Size Flavor grape Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63102-110-16 474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/13/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 08/13/2015 Labeler - ACTIPHARMA, LLC (079340948)
