ACTIDOM DMX- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution

ACTIDOM DMX by

Drug Labeling and Warnings

ACTIDOM DMX by is a Otc medication manufactured, distributed, or labeled by Actipharma, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients (in each 5 mL tsp)

Dextromethorphan HBr, 30 mg
Guaifenesin, 200 mg
Phenylephrine HCl, 10 mg

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Uses  Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes Temporarily relieves these symptoms occurring with a cold: nasal congestion, cough due to minor throat and bronchial irritation.

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

Directions do not take more than 4 doses in any 24-hour period.

Adults and Children 12 years of age and over	5 mL (1tsp), every 6 hours
Children under 12 years of age	ask a doctor

INACTIVE INGREDIENT

Inactive ingredients: Citric acid, D&C Red 40, FD&C Blue#1, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose.

OTHER SAFETY INFORMATION

Other information  Store at room temperature 15° - 30ºC (59º - 86ºF)  protect from freezing  protect from light  Avoid excessive heat or humidity. TAMPER EVIDENT: Do not use if inner seal is torn, broken or missing.

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 solution

Product 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)