perrigo tussin dm drug facts

perrigo tussin dm drug facts
SPL v1
SPL
SPL Set ID f95a7302-a6de-4acf-bcb7-1e4f52a10a8e
Route
oral
Published
Effective Date 2013-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (10 mg) guaifenesin (100 mg)
Inactive Ingredients
aspartame benzoic acid glycerin hydroxyethyl cellulose (5500 mpa.s at 2%) polyethylene glycols water

Identifiers & Packaging

Marketing Status
otc monograph final active Since 1994-09-20

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg


Medication Information

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
Purpose

Cough suppressant

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
age dose

adults and children

12 years and over

2 teaspoons

every 4 hours
children under 12 years do not use
Other Information
  • Phenylketonurics: contains phenylalanine 15 mg per teaspoon
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients

aspartame, benzoic acid, flavors, glycerin, hydroxyethyl cellulose, polyethylene glycol, purified water

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg

Principal Display Panel

Non-Drowsy

See New Dosing Directions

Tussin DM

Cough & Chest Congestion

Sugar-Free

Cough Suppressant (Dextromethorphan HBr)

Expectorant (Guaifenesin)

Relieves:

Coughs

Chest Congestion

Mucus

Specially Formulated for Diabetics

Adult

For Ages 12 & Over

Alcohol & Sugar Free

Compare to active ingredients of Robitussin® Cough & Chest Congestion Sugar-Free DM

NDC 68258-8905-04

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.
Questions Or Comments?

1-800-719-9260

Stop Use and Ask A Doctor If

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 Ingredient (in Each 5 Ml Tsp)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg


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
Purpose

Cough suppressant

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
age dose

adults and children

12 years and over

2 teaspoons

every 4 hours
children under 12 years do not use
Other Information (Other information)
  • Phenylketonurics: contains phenylalanine 15 mg per teaspoon
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

aspartame, benzoic acid, flavors, glycerin, hydroxyethyl cellulose, polyethylene glycol, purified water

Principal Display Panel

Non-Drowsy

See New Dosing Directions

Tussin DM

Cough & Chest Congestion

Sugar-Free

Cough Suppressant (Dextromethorphan HBr)

Expectorant (Guaifenesin)

Relieves:

Coughs

Chest Congestion

Mucus

Specially Formulated for Diabetics

Adult

For Ages 12 & Over

Alcohol & Sugar Free

Compare to active ingredients of Robitussin® Cough & Chest Congestion Sugar-Free DM

NDC 68258-8905-04

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.
Questions Or Comments? (Questions or comments?)

1-800-719-9260

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

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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)
  • 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 Ingredient (in Each 5 Ml Tsp) (Active ingredient (in each 5 mL tsp))

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg


Advanced Ingredient Data


Raw Label Data

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