Deconex Dmx Tablets

Deconex Dmx Tablets
SPL v6
SPL
SPL Set ID 8aab8e5c-1633-2e5a-e053-2a95a90adcc5
Route
ORAL
Published
Effective Date 2019-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (17.5 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Hypromelloses Maltodextrin Povidone Cellulose, Microcrystalline Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: POLY;730 Shape: capsule Color: orange Size: 17 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-06-01

Description

Active ingredients (in each tablet) Dextromethorphan HBr 17.5 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Purpose

Cough Suppressant Expectorant Nasal Decongestant


Medication Information

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Description

Active ingredients (in each tablet) Dextromethorphan HBr 17.5 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of nasal passages
Section 50565-1

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

Section 53414-9

If pregnant or breast feeding, ask a health professional before use.

Warnings

Do not exceed recommended dosage.

Directions

Do not exceed recommended dosage.

Adults and children 12

years of age and over:



1 tablet every 4 hours,

not to exceed 6 tablets

in 24 hours

Children 6 to under 12

years of age:



1/2 tablet every 4 hours,

not to exceed 3 tablets

in 24 hours

Children under 6 years

of age:

Consult a physician.





Drug Facts

Active ingredients (in each tablet)



Dextromethorphan HBr 17.5 mg



Guaifenesin 400 mg



Phenylephrine HCl 10 mg

Other Information

Store at 15°- 30° C (59°- 86° F).

Supplied in a tight, light-resistant container with a child-resistant cap.

Deconex DMX Tablets are orange, oblong, capsule-shaped, scored tablets, debossed "POLY" bisect "730" on one side and blank on the other side.

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 100 tablets label:

NDC 50991-740-01







DECONEX DMX



TABLETS

COUGH SUPPRESSANT · EXPECTORANT



NASAL DECONGESTANT

Each tablet contains:



Dextromethorphan HBr........................17.5 mg



Guaifenesin......................................400 mg



Phenylephrine HCl..............................10 mg

Tamper evident by foil seal under cap.



Do not use if foil seal is broken or missing.

Distributed by:



Poly Pharmaceuticals

Huntsville, AL

100 tablets

Rev. 06-19

Inactive Ingredients

Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, Hypromellose, Maltodextrin, Povidone, Silicified Microcrystalline Cellulose, and Stearic Acid.

Questions? Comments?

Call 1-800-882-1041.

Manufactured for:



Poly Pharmaceuticals



Huntsville, AL



1(800) 882-1041

Rev: 06/19

Do Not Use This Product
  • 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.

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.  A persistent cough may be a sign of a serious condition.
  • new symptoms occur

Ask A Doctor Before Use If You Have
  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland


Structured Label Content

Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of nasal passages
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.

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional before use.

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Warnings

Do not exceed recommended dosage.

Directions

Do not exceed recommended dosage.

Adults and children 12

years of age and over:



1 tablet every 4 hours,

not to exceed 6 tablets

in 24 hours

Children 6 to under 12

years of age:



1/2 tablet every 4 hours,

not to exceed 3 tablets

in 24 hours

Children under 6 years

of age:

Consult a physician.





Drug Facts

Active ingredients (in each tablet)



Dextromethorphan HBr 17.5 mg



Guaifenesin 400 mg



Phenylephrine HCl 10 mg

Other Information (Other information)

Store at 15°- 30° C (59°- 86° F).

Supplied in a tight, light-resistant container with a child-resistant cap.

Deconex DMX Tablets are orange, oblong, capsule-shaped, scored tablets, debossed "POLY" bisect "730" on one side and blank on the other side.

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 100 tablets label:

NDC 50991-740-01







DECONEX DMX



TABLETS

COUGH SUPPRESSANT · EXPECTORANT



NASAL DECONGESTANT

Each tablet contains:



Dextromethorphan HBr........................17.5 mg



Guaifenesin......................................400 mg



Phenylephrine HCl..............................10 mg

Tamper evident by foil seal under cap.



Do not use if foil seal is broken or missing.

Distributed by:



Poly Pharmaceuticals

Huntsville, AL

100 tablets

Rev. 06-19

Inactive Ingredients (Inactive ingredients)

Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, Hypromellose, Maltodextrin, Povidone, Silicified Microcrystalline Cellulose, and Stearic Acid.

Questions? Comments?

Call 1-800-882-1041.

Manufactured for:



Poly Pharmaceuticals



Huntsville, AL



1(800) 882-1041

Rev: 06/19

Do Not Use This Product (Do not use this product)
  • 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.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.  A persistent cough may be a sign of a serious condition.
  • new symptoms occur

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland


Advanced Ingredient Data


Raw Label Data

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