Q-tussin Dm 0855

Q-tussin Dm 0855
SPL v1
SPL
SPL Set ID ae91e751-f3d7-4fef-ba92-67e4bf327373
Route
ORAL
Published
Effective Date 2012-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Glucose Oxidase Water Saccharin Sodium Sodium Benzoate

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH FINAL Active Since 1999-11-16

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant

Expectorant

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg

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

Made in the USA

for Qualitest Pharmaceuticals

Huntsville, AL 35811

Rev. 7/09 R4

8281171  0855





Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma       74146

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 53414-9

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

Warnings

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.

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 (yr) 

dose (tsp) 

adults and children

12 years and over 

2 teaspoons

every 4 hours 

children under

12 years 

do not use

Other Information
  • store at 15° to 30°C (59° to 86°F)
  • dosage cup provided

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive Ingredients

citric acid, FD&C red #40, flavors, glycerin, high fructose corn syrup, liquid glucose, purified water, saccharin sodium, sodium benzoate

Principal Display Panel
NDC 54868-1986-1

118 mL



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 Ingredients (in Each 5 Ml = 1 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
Section 42229-5 (42229-5)

Made in the USA

for Qualitest Pharmaceuticals

Huntsville, AL 35811

Rev. 7/09 R4

8281171  0855





Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma       74146

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 53414-9 (53414-9)

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

Purpose

Cough suppressant

Expectorant

Warnings

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.

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 (yr) 

dose (tsp) 

adults and children

12 years and over 

2 teaspoons

every 4 hours 

children under

12 years 

do not use

Other Information (Other information)
  • store at 15° to 30°C (59° to 86°F)
  • dosage cup provided

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive Ingredients (Inactive ingredients)

citric acid, FD&C red #40, flavors, glycerin, high fructose corn syrup, liquid glucose, purified water, saccharin sodium, sodium benzoate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)
NDC 54868-1986-1

118 mL



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 Ingredients (in Each 5 Ml = 1 Tsp) (Active ingredients (in each 5 mL = 1 tsp))

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg


Advanced Ingredient Data


Raw Label Data

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