SPL v6
SPL
SPL Set ID dd31f86b-f59e-459a-8e5f-176828706a4a
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 High Fructose Corn Syrup Menthol Water Saccharin Sodium Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-11-19

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 IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

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 and children 12 years and over  2 teaspoonfuls every 4 hours
 chilldren under 12 years  do not use

Drug Facts

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Other Information
  • Keep carton for full Direction for use.
  • store at 20°-25°C (68°-77°F)
  • do not refrigerate
  • dosage cup provided
  • sodium  3 mg per teaspoonful
Inactive Ingredients

Anhydrous citric acid, dextrose, FD and 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 persistant headache.

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.

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 Taking If You Have
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, bronchitis or emphysema
Discount Drug Mart Food Fair Tussin Dm Product Label

*COMPARE TO THE ACTIVE INGREDIENTS IN ROBITUSSIN® PEAK COLD COUGH AND CHEST CONGESTION DM

DISCOUNT

drug mart

FOOD FAIR

Tussin DM

Dextromethorphan HBr/ Guaifenesin

NON-DROWSY

COUGH SUPPRESSANT

EXPECTORANT

Helps Loosen

Chest Congestion

Cough Formula

for ages 12 & over

8 FL OZ (237 mL)

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

BX-039

SATISFACTION GUARANTEED

IF DISSASIFIED , RETURN UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

res


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 IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

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 and children 12 years and over  2 teaspoonfuls every 4 hours
 chilldren under 12 years  do not use

Drug Facts

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Other Information (Other information)
  • Keep carton for full Direction for use.
  • store at 20°-25°C (68°-77°F)
  • do not refrigerate
  • dosage cup provided
  • sodium  3 mg per teaspoonful
Inactive Ingredients (Inactive ingredients)

Anhydrous citric acid, dextrose, FD and 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 persistant 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.

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 Taking If You Have (Ask a doctor before taking if you have)
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, bronchitis or emphysema
Discount Drug Mart Food Fair Tussin Dm Product Label (DISCOUNT drug mart FOOD FAIR Tussin DM product label)

*COMPARE TO THE ACTIVE INGREDIENTS IN ROBITUSSIN® PEAK COLD COUGH AND CHEST CONGESTION DM

DISCOUNT

drug mart

FOOD FAIR

Tussin DM

Dextromethorphan HBr/ Guaifenesin

NON-DROWSY

COUGH SUPPRESSANT

EXPECTORANT

Helps Loosen

Chest Congestion

Cough Formula

for ages 12 & over

8 FL OZ (237 mL)

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

BX-039

SATISFACTION GUARANTEED

IF DISSASIFIED , RETURN UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

res


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