Tussin Dm

Tussin Dm
SPL v1
SPL
SPL Set ID 3a101213-5d6a-4f20-8f67-2dcda375d73b
Route
ORAL
Published
Effective Date 2014-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Sodium Benzoate Citric Acid Monohydrate Sorbitol Saccharin Sodium Sucralose Fd&c Red No. 40 Propylene Glycol Glycerin Sodium Citrate Menthol Water

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-04-10

Description

Active ingredients (in each 5 mL tsp): Purpose Dextromethorphan HBr, USP 10 mg Cough suppressant Guaifenesin, USP 100 mg Expectorant


Medication Information

Description

Active ingredients (in each 5 mL tsp): Purpose Dextromethorphan HBr, USP 10 mg Cough suppressant Guaifenesin, USP 100 mg Expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold; helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

Section 42229-5

Do not exceed recommended dose

Section 50565-1

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

Section 50566-9

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.

Section 50569-3

Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) or a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Section 53414-9

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

Section 55105-1
Active ingredients (in each 5 mL tsp): Purpose
Dextromethorphan HBr, USP 10 mg Cough suppressant
Guaifenesin, USP 100 mg Expectorant
Directions

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

  • this adult product is not intended for use in children under 12 years of age
  • mL = milliliter; tsp = teaspoonful
age dose
adults and children 12 years and over 10 mL (2 tsp) every 4 hours
children under 12 years 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.
Other Information

Each tsp contains: sodium 6.5 mg. Store at 20°-25°C (68°-77°F), Do not refrigerate.

Dosage cup provided.

Inactive Ingredients

citric acid, FD & C Red # 40, flavor, glycerin, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Principal Display Panel 237 Ml Bottle Label

davAgen

pharmaceutical

NDC 76140-106-08

Adults & Children Ages 12 & Older

Tussin DM

Cough &

Chest Congestion

Cough Suppressant - Dextromethorphan HBr

Expectorant - Guaifenesin

For Relief of:

  • Cough
  • Chest Congestion & Mucus

8 FL OZ (237 mL)


Structured Label Content

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold; helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

Section 42229-5 (42229-5)

Do not exceed recommended dose

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.

Section 50569-3 (50569-3)

Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) or a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each 5 mL tsp): Purpose
Dextromethorphan HBr, USP 10 mg Cough suppressant
Guaifenesin, USP 100 mg Expectorant
Directions

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

  • this adult product is not intended for use in children under 12 years of age
  • mL = milliliter; tsp = teaspoonful
age dose
adults and children 12 years and over 10 mL (2 tsp) every 4 hours
children under 12 years do not use
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.
Other Information (Other information)

Each tsp contains: sodium 6.5 mg. Store at 20°-25°C (68°-77°F), Do not refrigerate.

Dosage cup provided.

Inactive Ingredients (Inactive ingredients)

citric acid, FD & C Red # 40, flavor, glycerin, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Principal Display Panel 237 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label)

davAgen

pharmaceutical

NDC 76140-106-08

Adults & Children Ages 12 & Older

Tussin DM

Cough &

Chest Congestion

Cough Suppressant - Dextromethorphan HBr

Expectorant - Guaifenesin

For Relief of:

  • Cough
  • Chest Congestion & Mucus

8 FL OZ (237 mL)


Advanced Ingredient Data


Raw Label Data

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