drug Facts

drug Facts
SPL v3
SPL
SPL Set ID 6bbf5b3a-ecc2-46f7-84a9-db4d3fcf4100
Route
ORAL
Published
Effective Date 2013-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Fd&c Red No. 40 Glycerin Propylene Glycol Water Fructose Sodium Chloride Sucrose Benzoic Acid Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-12-01

Description

Dextromethorphan HBr, 10mg Guaifenesin, 100mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr, 10mg Guaifenesin, 100mg

Section 50565-1

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

Section 51945-4

Section 53414-9

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

uses
  • Temporarily quiets coughs due to minor throat and bronchial irritation associated with the common cold.
  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
purpose

Cough suppressant

Expectorant

warnings

Do not use

  • if you are now taking a perscription 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're uncertain whether your prescription drug contains MAOI, ask a doctor or pharmacist before taking this product.
directions
  • Follow dosage below or use as directed by a doctor
  • Do not exceed 6 dosages in 24 hours
  • Adults and children 12 years or age and over, 2 teaspoonfuls every 4 hours
  • Children 6 to under 12 years of age, 1 teaspoonful every 4 hours
  • Children under 6 years of age, consult a doctor
Other Information

Store from 15° - 30°C (59° - 86°F)

Active Ingredients 

Dextromethorphan HBr, 10mg

Guaifenesin, 100mg

inactive Ingredients

Alcohol 4.75%, benzoic acid, FD&C red #40, flavors, fructose, glycerin, propylene glycol, sodium chloride, sucrose, water.

questions Or Comments
  • 1-800-950-5337, M-F, 9am-4pm, PST
  • Visit our website at:  www.leepharmaceuticals.com
stop Use and Ask A Doctor If
  • cough persists for more than one week
  • cough tends to recur or is accompanied by fever, rash or persistent headache.  A persistent cough may be a sign of a serious condition.
Ask A Doctor Before Use If You Have
  • a persistent chronic cough such as occurs with smoking, asthma or emphysema.
  • excessive phlegm (mucus).

Structured Label Content

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

uses (Uses)
  • Temporarily quiets coughs due to minor throat and bronchial irritation associated with the common cold.
  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
purpose (Purpose)

Cough suppressant

Expectorant

warnings (Warnings)

Do not use

  • if you are now taking a perscription 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're uncertain whether your prescription drug contains MAOI, ask a doctor or pharmacist before taking this product.
directions (Directions)
  • Follow dosage below or use as directed by a doctor
  • Do not exceed 6 dosages in 24 hours
  • Adults and children 12 years or age and over, 2 teaspoonfuls every 4 hours
  • Children 6 to under 12 years of age, 1 teaspoonful every 4 hours
  • Children under 6 years of age, consult a doctor
Other Information (Other information)

Store from 15° - 30°C (59° - 86°F)

Active Ingredients  (Active ingredients )

Dextromethorphan HBr, 10mg

Guaifenesin, 100mg

inactive Ingredients (Inactive ingredients)

Alcohol 4.75%, benzoic acid, FD&C red #40, flavors, fructose, glycerin, propylene glycol, sodium chloride, sucrose, water.

questions Or Comments (Questions or Comments)
  • 1-800-950-5337, M-F, 9am-4pm, PST
  • Visit our website at:  www.leepharmaceuticals.com
stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough persists for more than one week
  • cough tends to recur or is accompanied by fever, rash or persistent headache.  A persistent cough may be a sign of a serious condition.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a persistent chronic cough such as occurs with smoking, asthma or emphysema.
  • excessive phlegm (mucus).

Advanced Ingredient Data


Raw Label Data

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