drug facts

drug facts
SPL v3
SPL
SPL Set ID 9708c338-f00e-4fc2-a759-44b65db0860d
Route
oral
Published
Effective Date 2019-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (10 mg) guaifenesin (200 mg)
Inactive Ingredients
acesulfame potassium aspartame hypromellose, unspecified menthol, unspecified form methylparaben polyethylene glycol, unspecified potassium sorbate water anhydrous citric acid

Identifiers & Packaging

Marketing Status
otc monograph final active Since 1995-07-03

Purpose

Cough Suppressant Expectorant

Description

Dextromethorphan hydrobromide 10 mg Guaifenesin 200 mg


Medication Information

Uses
  • temporarily relieves cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus
Purpose

Cough Suppressant Expectorant

Directions
  • take every 4 hours
  • do not exceed 6 doses in 24 hours

adults & children 12 years & over

10 mL (2 teaspoonfuls)

children under 12 years of age

ask a doctor

Other Information
  • Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
  • store at room temperature 20-25ºC (68-77ºF)
  • keep tightly closed
Inactive Ingredients

Acesulfame K, artificial cherry & vanilla flavors, aspartame, hypromellose, menthol, methylparaben, polyethylene glycol, potassium sorbate, and purified water. Citric acid may be used to adjust pH.

Description

Dextromethorphan hydrobromide 10 mg Guaifenesin 200 mg

Purposes

Cough Suppressant

Expectorant

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 two 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?

Call 1-800-899-3116, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST.

Serious side effects associated with use of this product may be reported to this number.

Rev #064:03 12/11

Stop Use and Ask A Doctor If
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts
  •  
    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.

Package Principal Display Panel

NDC 61787-064-08

Diabetic Tussin®

DM MAXIMUM STRENGTH

Cough Suppressant & Expectorant

RELIEVES COUGHS

SOOTHES THROAT

RELIEVES CHEST CONGESTION

Liquid

No Sodium, Dye, Sorbitol, Fructose

SAFE FOR DIABETICS

SUGAR & ALCOHOL FREE!

GLUTEN FREE

8 FL OZ (237 mL)

Active Ingredients (in Each 5 Ml)

Dextromethorphan hydrobromide 10 mg

Guaifenesin 200 mg

Ask A Doctor Before Use If You Have
  • a cough that occurs with too much phlegm (mucus)
  • a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Structured Label Content

Uses
  • temporarily relieves cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus
Directions
  • take every 4 hours
  • do not exceed 6 doses in 24 hours

adults & children 12 years & over

10 mL (2 teaspoonfuls)

children under 12 years of age

ask a doctor

Other Information (Other information)
  • Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
  • store at room temperature 20-25ºC (68-77ºF)
  • keep tightly closed
Inactive Ingredients (Inactive ingredients)

Acesulfame K, artificial cherry & vanilla flavors, aspartame, hypromellose, menthol, methylparaben, polyethylene glycol, potassium sorbate, and purified water. Citric acid may be used to adjust pH.

Purposes

Cough Suppressant

Expectorant

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 two 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?)

Call 1-800-899-3116, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST.

Serious side effects associated with use of this product may be reported to this number.

Rev #064:03 12/11

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts
  •  
    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.

Package Principal Display Panel

NDC 61787-064-08

Diabetic Tussin®

DM MAXIMUM STRENGTH

Cough Suppressant & Expectorant

RELIEVES COUGHS

SOOTHES THROAT

RELIEVES CHEST CONGESTION

Liquid

No Sodium, Dye, Sorbitol, Fructose

SAFE FOR DIABETICS

SUGAR & ALCOHOL FREE!

GLUTEN FREE

8 FL OZ (237 mL)

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

Dextromethorphan hydrobromide 10 mg

Guaifenesin 200 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a cough that occurs with too much phlegm (mucus)
  • a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Advanced Ingredient Data


Raw Label Data

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