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

Description

Dextromethorphan HBr, USP 10mg Guaifenesin, USP 200mg

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


Medication Information

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

Description

Dextromethorphan HBr, USP 10mg Guaifenesin, USP 200mg

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


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.

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

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

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

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

Indications and Usage (34067-9)


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


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.

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

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

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

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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