Tussnex Fm Dm Max

Tussnex Fm Dm Max
SPL v4
SPL
SPL Set ID 0bae53e3-9661-4bc6-9fcc-da7fa131b034
Route
ORAL
Published
Effective Date 2022-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Anhydrous Citric Acid Dextrose D&c Red No. 33 Fd&c Red No. 40 Glycerin Methylparaben Potassium Sorbate Propylene Glycol Propylparaben Water Saccharin Sodium Sodium Hydroxide Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-05-01

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant

Expectorant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Pdp

compare to active ingredients in Mucinex®Fast-MaxTMDM Max

Maximum strength

Tussnex FM DM Max

Dextromethorphan HBr

Cough suppressant

Guaifenesin

Expectorant

Multi-symptom

Relieves chest congestion

Thins and loosens mucus

Soothes cough

Dosing lasts 4 hours

For ages 12 & over

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get to sleep
Warnings

Do not use

  • for children under 12 years of age
  • 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.
Directions
  • do not take more than 6 doses in any 24 hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • Adults & children 12 years & older: 20mL every 4 hours
  • Children under 12 years of age: Do not use
Other Information
  • each 20 mL contains: potassium 20 mg, sodium 20 mg
  • store between 15-30oC (59-86oF)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients

citric acid anhydrous, D&C red 33, dextrose, FD&C red 40, flavors, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum

When Using This Product
  • do not use more than directed
Stop Use and Ask A Doctor If
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Active Ingredients (in Each 20 Ml)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have
  • persistent or chronic cough such as occurs with smoking, asthma, chronuc bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)

Structured Label Content

Pdp (PDP)

compare to active ingredients in Mucinex®Fast-MaxTMDM Max

Maximum strength

Tussnex FM DM Max

Dextromethorphan HBr

Cough suppressant

Guaifenesin

Expectorant

Multi-symptom

Relieves chest congestion

Thins and loosens mucus

Soothes cough

Dosing lasts 4 hours

For ages 12 & over

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get to sleep
Purpose

Cough suppressant

Expectorant

Warnings

Do not use

  • for children under 12 years of age
  • 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.
Directions
  • do not take more than 6 doses in any 24 hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • Adults & children 12 years & older: 20mL every 4 hours
  • Children under 12 years of age: Do not use
Other Information (Other information)
  • each 20 mL contains: potassium 20 mg, sodium 20 mg
  • store between 15-30oC (59-86oF)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients (Inactive ingredients)

citric acid anhydrous, D&C red 33, dextrose, FD&C red 40, flavors, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum

When Using This Product (When using this product)
  • do not use more than directed
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 mL))

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • persistent or chronic cough such as occurs with smoking, asthma, chronuc bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)

Advanced Ingredient Data


Raw Label Data

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