Tussin Cough Dm  503

Tussin Cough Dm  503
SPL v8
SPL
SPL Set ID e25727d0-7dd7-4ef5-b064-7938679f075f
Route
ORAL
Published
Effective Date 2023-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-01-01

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
Warnings

Do not use

  • in a child under 12 years of age
  • 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

Age                                       Dose

adults & children                     2 teaspoonfuls

12 years and over                  every 4 hours

children under 12 years           do not use

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Other Information

  • store at 20-25° C (66-77° F)
  • do not refrigerate
  • dosage cup provided
  • sodium 3 mg per teaspoon
Inactive Ingredients

Anhydrous citric acid, dextrose, FD & C red # 40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

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.

If Pregnant Or Breast Feeding

ask a health professional before use.

Tussin Cough Dm Product Label

* COMPARE TO ROBITUSSIN® PEAK COLD ACTIVE INGREDIENTS



CVP® CONSUMER VALUE PRODUCTS



TUSSIN COUGH EXPECTORANT COUGH SUPPRESSANT DM

NON-DROWSY COUGH FORMULA

  • ADULT
  • FOR AGES 12 AND OVER
  • CONTROLS COUGH
  • HELPS LOOSEN CHEST CONGESTION

4 FL OZ (118 Ml)

* This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin® Peak Cold

Box-001 Rev 01

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING



Distributed by: Salado Sales, Inc.  P.O. Box 6115 Temple, TX 76503  www.saladosales.com

LOT.

EXP.

res

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 You 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
Drug Factsactive Ingredients ( in Each 5 Ml 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
Purpose

Cough Suppressant

Expectorant

Warnings

Do not use

  • in a child under 12 years of age
  • 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

Age                                       Dose

adults & children                     2 teaspoonfuls

12 years and over                  every 4 hours

children under 12 years           do not use

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Other Information (Other information)

  • store at 20-25° C (66-77° F)
  • do not refrigerate
  • dosage cup provided
  • sodium 3 mg per teaspoon
Inactive Ingredients (Inactive ingredients)

Anhydrous citric acid, dextrose, FD & C red # 40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Stop Use and Ask A Doctor If (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.

If Pregnant Or Breast Feeding (If Pregnant Or Breast-Feeding)

ask a health professional before use.

Tussin Cough Dm Product Label (Tussin Cough DM product label)

* COMPARE TO ROBITUSSIN® PEAK COLD ACTIVE INGREDIENTS



CVP® CONSUMER VALUE PRODUCTS



TUSSIN COUGH EXPECTORANT COUGH SUPPRESSANT DM

NON-DROWSY COUGH FORMULA

  • ADULT
  • FOR AGES 12 AND OVER
  • CONTROLS COUGH
  • HELPS LOOSEN CHEST CONGESTION

4 FL OZ (118 Ml)

* This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin® Peak Cold

Box-001 Rev 01

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING



Distributed by: Salado Sales, Inc.  P.O. Box 6115 Temple, TX 76503  www.saladosales.com

LOT.

EXP.

res

Keep Out of Reach of Children. (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 You Use If You Have (Ask A Doctor Before You 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
Drug Factsactive Ingredients ( in Each 5 Ml Tsp) (Drug FactsActive ingredients ( in each 5 mL tsp))

Dextromethorphan HBr, USP 10 mg



Guaifenesin, USP 100 mg


Advanced Ingredient Data


Raw Label Data

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