Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID c7e6a5c2-245c-4aa7-adf0-a0baf56ce9ac
Route
ORAL
Published
Effective Date 2018-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Acesulfame Potassium Cherry Vanilla Aspartame Hypromellose, Unspecified Menthol, Unspecified Form Methylparaben Potassium Sorbate Water Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 1997-05-01
Description

Dextromethorphan HBr 10 mg Guaifenesin 100 mg

Purpose

Cough Suppressant Expectorant

How Supplied

Product: 68151-0062 NDC: 68151-0062-1 5 mL in a CUP, UNIT-DOSE

Medication Information

Purpose

Cough Suppressant Expectorant

How Supplied

Product: 68151-0062

NDC: 68151-0062-1 5 mL in a CUP, UNIT-DOSE

Description

Dextromethorphan HBr 10 mg Guaifenesin 100 mg

Uses
  • temporarily relieves cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus
Storage
  • store at room temperature 20-25ºC (68-77ºF)
  • keep tightly closed
Purposes

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 6 years to under 12 years 5 mL (1 teaspoonful)
children 2 years to under 6 years 2.5 mL (½ teaspoonful)
children under 2 years ask a doctor
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.

Other Information

Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)

Inactive Ingredients

Acesulfame potassium, artificial cherry flavor, artificial vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

Questions and 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.

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.

Active Ingredients (in Each 5 Ml)

Dextromethorphan HBr 10 mg

Guaifenesin 100 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
Diabetic Tussin Dm (dextromethorphan Hydrobromide and Guaifenesin) Liquid

Structured Label Content

Uses
  • temporarily relieves cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus
Storage
  • store at room temperature 20-25ºC (68-77ºF)
  • keep tightly closed
Purposes

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 6 years to under 12 years 5 mL (1 teaspoonful)
children 2 years to under 6 years 2.5 mL (½ teaspoonful)
children under 2 years ask a doctor
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.

How Supplied (HOW SUPPLIED)

Product: 68151-0062

NDC: 68151-0062-1 5 mL in a CUP, UNIT-DOSE

Other Information (Other information)

Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)

Inactive Ingredients (Inactive ingredients)

Acesulfame potassium, artificial cherry flavor, artificial vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

Questions and Comments? (Questions and 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.

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.

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

Dextromethorphan HBr 10 mg

Guaifenesin 100 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
Diabetic Tussin Dm (dextromethorphan Hydrobromide and Guaifenesin) Liquid (DIABETIC TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID)

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:31.541166 · Updated: 2026-03-14T22:55:03.293878