dextromethorphan hbr (cough supressant)

dextromethorphan hbr (cough supressant)
SPL v2
SPL
SPL Set ID 0f349533-a87a-4512-b23c-d34854d73bc1
Route
oral
Published
Effective Date 2012-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (10 mg) guaifenesin (200 mg)
Inactive Ingredients
gelatin glycerin polyethylene glycol 1000 povidone povidone k30 propylene glycol fd&c red no. 40 sorbitol titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 601 Shape: oval Color: red Size: 20 mm Score: 1
Marketing Status
otc monograph final active Since 2015-11-08

Purpose

Cough Suppressant Expectorant

Description

(in each liquid filled capsule) Dextromethorphan Hydrobromide, USP 10mg Guaifenesin, USP 200mg


Medication Information

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

  • cough that occurs with too much phlegm(mucus)
  • cough that lasts or is chronic such as occur with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. This could be signs of a serious condition.

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

Uses
  • Temporarily relieves cough due minor throat and bronchial irritation as may occur with a cold
  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Purpose

Cough Suppressant

Expectorant

Directions
  • Do not take more than 12 capsules in any 24 hour period
  • This adult product is not intend for use in children under 12 years of age
                               Age               dose
    Adults and children 12 years and over 2 capsules every 4 hours
    Children under 12 years Do not use
Other Information
  • store at 20-25 °C(68-77 °F)
  • avoid excessive heat above 40 °C (104°F)
Inactive Ingredients

FD&C Red No 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, providone (PVP K-30), purified water, special sorbitol, titanium dioxide

Description

(in each liquid filled capsule) Dextromethorphan Hydrobromide, USP 10mg Guaifenesin, USP 200mg

Active Ingredient

(in each liquid filled capsule)

Dextromethorphan Hydrobromide, USP 10mg

Guaifenesin, USP 200mg

Questions Or Comments

Toll free 1-855-314-1850

Keep Out of Reach of Children.

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

Package Label.principal Display Panel

Cough and Congestion DM,

NDC:76168-060-37  16 Softgel Liquid filled


Structured Label Content

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

  • cough that occurs with too much phlegm(mucus)
  • cough that lasts or is chronic such as occur with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. This could be signs of a serious condition.

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

Uses
  • Temporarily relieves cough due minor throat and bronchial irritation as may occur with a cold
  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Purpose

Cough Suppressant

Expectorant

Directions
  • Do not take more than 12 capsules in any 24 hour period
  • This adult product is not intend for use in children under 12 years of age
                               Age               dose
    Adults and children 12 years and over 2 capsules every 4 hours
    Children under 12 years Do not use
Other Information
  • store at 20-25 °C(68-77 °F)
  • avoid excessive heat above 40 °C (104°F)
Inactive Ingredients

FD&C Red No 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, providone (PVP K-30), purified water, special sorbitol, titanium dioxide

Active Ingredient

(in each liquid filled capsule)

Dextromethorphan Hydrobromide, USP 10mg

Guaifenesin, USP 200mg

Questions Or Comments (Questions or Comments)

Toll free 1-855-314-1850

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Cough and Congestion DM,

NDC:76168-060-37  16 Softgel Liquid filled


Advanced Ingredient Data


Raw Label Data

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