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

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg


Medication Information

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.

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 (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

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg

Principal Display Panel
NDC 54868-1986-1

118 mL



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.

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

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.

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 (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



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.

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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