Actidom Dmx

Actidom Dmx
SPL v4
SPL
SPL Set ID 0166322e-7dbb-4658-a5c5-1d0525bb7655
Route
ORAL
Published
Effective Date 2024-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (30 mg) Guaifenesin (200 mg) Phenylephrine (10 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Red No. 40 Fd&c Blue No. 1 Glycerin Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-08-13

Description

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

Purpose

Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Cough suppressant Expectorant Nasal decongestant

Description

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

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.

Section 42229-5

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.

Section 50565-1

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

Purposes

Cough suppressant

Expectorant

Nasal decongestant

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.

Packaging

Directions

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

AGE DOSE

Adults and Children 12 years

of age and over 

 Take 1 teaspoonfuls

(5 mL) every 6 hours

 Children under 12 years of

   age

ask a doctor 

Drug Facts

Other Information

• Tamper Evident Feature: Do not use if safety seal is torn, cut or opened.

• Store at controlled room temperature 15° - 30ºC (59º - 86ºF).

• Avoid excessive heat or humidity.

Inactive Ingredients

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

Questions Or Comments?

call weekdays from 8AM to 4PM AST at 1.787.608.0882

Active Ingredients (in Each 5 Ml Tsp)

Dextromethorphan HBr, 30 mg

Guaifenesin, 200 mg

Phenylephrine HCl, 10 mg


Structured Label Content

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.

Section 42229-5 (42229-5)

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.

Section 50565-1 (50565-1)

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

Purposes

Cough suppressant

Expectorant

Nasal decongestant

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.

Packaging

Directions

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

AGE DOSE

Adults and Children 12 years

of age and over 

 Take 1 teaspoonfuls

(5 mL) every 6 hours

 Children under 12 years of

   age

ask a doctor 

Drug Facts

Other Information (Other information)

• Tamper Evident Feature: Do not use if safety seal is torn, cut or opened.

• Store at controlled room temperature 15° - 30ºC (59º - 86ºF).

• Avoid excessive heat or humidity.

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

call weekdays from 8AM to 4PM AST at 1.787.608.0882

Active Ingredients (in Each 5 Ml Tsp) (Active ingredients (in each 5 mL tsp))

Dextromethorphan HBr, 30 mg

Guaifenesin, 200 mg

Phenylephrine HCl, 10 mg


Advanced Ingredient Data


Raw Label Data

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