maximum strength tussin dm

maximum strength tussin dm
SPL v3
SPL
SPL Set ID 9bffd874-313f-4fbb-a196-b76bd7160f92
Route
oral
Published
Effective Date 2013-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (10 mg) guaifenesin (200 mg)
Inactive Ingredients
carboxymethylcellulose sodium citric acid monohydrate d&c red no. 33 fd&c red no. 40 glycerin high fructose corn syrup menthol polyethylene glycol 400 propylene glycol water saccharin sodium sodium benzoate xanthan gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
otc monograph final active Since 2009-07-01

Purpose

Cough suppressant Expectorant Uses helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves: cough due to minor bronchial irritation as may occur with a cold or inhaled irritants the impulse to cough

Description

Dextromethorphan HBr, 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 MAOI, ask a doctor or pharmacist before taking this product.

Indications and Usage


Purpose

Cough suppressant Expectorant Uses helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves: cough due to minor bronchial irritation as may occur with a cold or inhaled irritants the impulse to cough

Directions
  • shake well before using
  • do not take more than 6 doses in any 24-hour period
  • only use the measuring cup that is included with this product for accurate dosing




Age

Dose

adults and children 12 years and over

2 tsp (10ml) every 4 hours

children under 12 years

do not use









Other Information
  • each teaspoon contains: sodium 5 mg
  • store at 20-25oC (68-77oF)
  • do not refrigerate
  • alcohol-free
  • measuring cup provided

Description

Dextromethorphan HBr, USP 10mg Guaifenesin, USP 200mg

Principal Display Panel

NDC 59779-967-04



Compare to the active ingredients in Adult Robitussin Cough and Chest congestion



Maximum Strength

Tussin DM

Adult Cough and chest congestion



Cough Supressant (Dextromethorphan HBr)

Expectorant (Guaifenesin)



Relieves:

Cough

Chest congestion/mucus

alcohol free

Non-Drowsy



For ages 12 and over

8 fl oz (237 mL)



1 image



2 image

Section 50565-1



Purposes

Cough suppressant

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

temporarily relieves:

  • cough due to minor bronchial irritation as may occur with a cold or inhaled irritants
  • the impulse to cough


Inactive Ingredients:

artificial and natural flavors, carboxymethylcellulose sodium, citric acid, Dand C red no. 33, FD and c red no. 40, glycerin, high fructose corn syrup, menthol, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, xanthan gum

Stop Use and Ask A Doctor If

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

Active Ingredients (in Each 5 Ml Tsp)

Dextromethorphan HBr, USP 10mg

Guaifenesin, USP 200mg


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 MAOI, ask a doctor or pharmacist before taking this product.

Indications and Usage (34067-9)


Directions
  • shake well before using
  • do not take more than 6 doses in any 24-hour period
  • only use the measuring cup that is included with this product for accurate dosing




Age

Dose

adults and children 12 years and over

2 tsp (10ml) every 4 hours

children under 12 years

do not use









Other Information (Other information)
  • each teaspoon contains: sodium 5 mg
  • store at 20-25oC (68-77oF)
  • do not refrigerate
  • alcohol-free
  • measuring cup provided

Principal Display Panel (Principal Display panel)

NDC 59779-967-04



Compare to the active ingredients in Adult Robitussin Cough and Chest congestion



Maximum Strength

Tussin DM

Adult Cough and chest congestion



Cough Supressant (Dextromethorphan HBr)

Expectorant (Guaifenesin)



Relieves:

Cough

Chest congestion/mucus

alcohol free

Non-Drowsy



For ages 12 and over

8 fl oz (237 mL)



1 image



2 image

Section 50565-1 (50565-1)



Purposes

Cough suppressant

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

temporarily relieves:

  • cough due to minor bronchial irritation as may occur with a cold or inhaled irritants
  • the impulse to cough


Inactive Ingredients: (Inactive ingredients:)

artificial and natural flavors, carboxymethylcellulose sodium, citric acid, Dand C red no. 33, FD and c red no. 40, glycerin, high fructose corn syrup, menthol, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, xanthan gum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

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

Dextromethorphan HBr, USP 10mg

Guaifenesin, USP 200mg


Advanced Ingredient Data


Raw Label Data

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