Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 5f8dffc8-ffee-4ca9-b37d-40ccad2ba86a
Route
ORAL
Published
Effective Date 2011-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg) Phenylephrine (5 mg)
Inactive Ingredients
Xanthan Gum Polysorbate 80 Sorbitol Sucralose Glycerin Sodium Benzoate Citric Acid Monohydrate Propylene Glycol Sucrose Menthol Fd&c Red No. 40 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-08-26

Description

(in each 5mL tsp) Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg Phenylephrine HCl, USP 5mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant

Expectorant

Description

(in each 5mL tsp) Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg Phenylephrine HCl, USP 5mg

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



Directions
  • do not take more than 6 doses in any 24-hour period


Age

Dose

adults and children 12 years and over

2 tsp every 4 hours

children 6 years to under 12 years

1 tsp every 4 hours

children 2 years to under 6 years

1/2 tsp every 4 hours

children under 2 years

ask a doctor

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.

Package Label

Tussin DM

Other Information
  • each teaspoon contains:sodium 1mg

  • store at 20-25°C (68-77°F)
  • alcohol-free
  • dosage cup provided
  • not a USP elixir

Active Ingredients

(in each 5mL tsp)

Dextromethorphan HBr, USP 10mg

Guaifenesin, USP 100mg

Phenylephrine HCl, USP 5mg

Inactive Ingredients

cherry flavor, citric acid, FD and C red no. 40, glycerin, sucrose, sucralose, menthol, propylene glycol, purified water, xanthan gum, polysorbate, sorbitol solution, sodium benzoate

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
  • cough lasts more than 7 days, comes back, or is accompanied by 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.

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

When Using This Product Do Not Use More Than Directed.




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

Purpose

Cough suppressant

Expectorant

Warnings



Directions
  • do not take more than 6 doses in any 24-hour period


Age

Dose

adults and children 12 years and over

2 tsp every 4 hours

children 6 years to under 12 years

1 tsp every 4 hours

children 2 years to under 6 years

1/2 tsp every 4 hours

children under 2 years

ask a doctor

Do Not Use (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.

Package Label (Package label)

Tussin DM

Other Information (Other information)
  • each teaspoon contains:sodium 1mg

  • store at 20-25°C (68-77°F)
  • alcohol-free
  • dosage cup provided
  • not a USP elixir

Active Ingredients (Active ingredients)

(in each 5mL tsp)

Dextromethorphan HBr, USP 10mg

Guaifenesin, USP 100mg

Phenylephrine HCl, USP 5mg

Inactive Ingredients (Inactive ingredients)

cherry flavor, citric acid, FD and C red no. 40, glycerin, sucrose, sucralose, menthol, propylene glycol, purified water, xanthan gum, polysorbate, sorbitol solution, sodium benzoate

Stop Use and Ask A Doctor If, (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
  • cough lasts more than 7 days, comes back, or is accompanied by 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. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (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

When Using This Product Do Not Use More Than Directed. (When using this product do not use more than directed.)




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