NDC | 63102-110-16 |
Set ID | 0166322e-7dbb-4658-a5c5-1d0525bb7655 |
Category | HUMAN OTC DRUG LABEL |
Packager | Actipharma, Inc |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Drug Facts
- Active Ingredients (in each 5 mL tsp)
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
WARNINGS
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, 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.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
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SPL UNCLASSIFIED SECTION
Manufactured in the USA for ActiPharma, Inc. Dorado, PR 00646. Tel: (787)608-0882
* Dometuss-DMX® is a registered trademark of Domel Laboratories. This product is not manufactured, distributed or marketed by Domel Laboratories.
Contains the same active ingredients as Dometuss®-DMX*
COUGH SUPPRESSANT
EXPECTORANT
NASAL DECONGESTANT
SUGAR FREE
ALCOHOL FREE
Grape Flavor
- Packaging
-
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 (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 final part341 08/13/2015 Labeler - Actipharma, Inc (079340948)