SPL v7
SPL
SPL Set ID 9654fdcd-d660-471f-bc5d-aa7dead7a4a8
Route
ORAL
Published
Effective Date 2022-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Anhydrous Citric Acid Dextrose D&c Red No. 33 Fd&c Red No. 40 Glycerin Maltitol Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-12-10

Description

Dextromethorphan HBr, USP 20 mg Guaifenesin 400 mg

Purpose

Cough Suppressant Expectorant


Medication Information

Purpose

Cough Suppressant

Expectorant

Description

Dextromethorphan HBr, USP 20 mg Guaifenesin 400 mg

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporaroly relieves these symptoms occuring with a cold:
  • cough due to minor throat and bronchial irritation
Warning

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

Do not use

  • for children 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
  • take only as recommended
  • use dosage cup
  • mL= millilter
  • do not take more than 6 doses in any 24-hour period
 Age  Dose
 Adults & children 12 years adn older  20 mL every 4 hours
 Children under 12 years of age  Do not use

Drug Facts

Dextromethorphan HBr, USP 20 mg

Guaifenesin 400 mg

Questions?

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

Other Information
  • each 20 mL contains: sodium 12 mg
  • dosage cup provided
  • store between 15-30°C (59-86°F)
  • do not refrigerate
Inactive Ingredients

anhydrous citric acid, dextrose, D&C Red # 33, FD&C Red # 40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, Xanthan gum

When Using This Product
  • do not use more than directed
Stop Use and Ask A Doctor If
  • cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistant headache. These could be signs of a serious condition.
If Pregnany 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
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
Discount Drug Mart Food Fair Maxium Strength Dm Max Product Label

*COMPARE TO THE ACTIVE INGREDIENTS IN MUCINEX® FAST-MAX™-DM MAX

LF-010

DISCOUNT

drug mart

FOOD FAIR

MAXIUM STRENGTH DM MAX

Dextromethorphan HBr/ Guaifenesin

COUGH SUPPRESSANT/

EXPECTORANT

Controls Cough

Thins & Loosens mucus

Relieves Chest Congestion

Adults

For Ages 12 & Over

6 FL OZ (177 mL)

* This product is not manufactured or distributed by Reckitt Benckiser Inc., distributor of MUCINEX® FAST-MAX™ DM MAX

LB - 010 LOT: EXP:

Peel Corner to Read Complete Drug Facts and Information

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
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporaroly relieves these symptoms occuring with a cold:
  • cough due to minor throat and bronchial irritation
Purpose

Cough Suppressant

Expectorant

Warning

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

Do not use

  • for children 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
  • take only as recommended
  • use dosage cup
  • mL= millilter
  • do not take more than 6 doses in any 24-hour period
 Age  Dose
 Adults & children 12 years adn older  20 mL every 4 hours
 Children under 12 years of age  Do not use

Drug Facts

Dextromethorphan HBr, USP 20 mg

Guaifenesin 400 mg

Questions?

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

Other Information (Other information)
  • each 20 mL contains: sodium 12 mg
  • dosage cup provided
  • store between 15-30°C (59-86°F)
  • do not refrigerate
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, dextrose, D&C Red # 33, FD&C Red # 40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, Xanthan gum

When Using This Product (When using this product)
  • do not use more than directed
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistant headache. These could be signs of a serious condition.
If Pregnany Or Breast Feeding, (If pregnany 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 Use If You Have (Ask a doctor before use if you have)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
Discount Drug Mart Food Fair Maxium Strength Dm Max Product Label (DISCOUNT drug mart FOOD FAIR MAXIUM STRENGTH DM MAX product label)

*COMPARE TO THE ACTIVE INGREDIENTS IN MUCINEX® FAST-MAX™-DM MAX

LF-010

DISCOUNT

drug mart

FOOD FAIR

MAXIUM STRENGTH DM MAX

Dextromethorphan HBr/ Guaifenesin

COUGH SUPPRESSANT/

EXPECTORANT

Controls Cough

Thins & Loosens mucus

Relieves Chest Congestion

Adults

For Ages 12 & Over

6 FL OZ (177 mL)

* This product is not manufactured or distributed by Reckitt Benckiser Inc., distributor of MUCINEX® FAST-MAX™ DM MAX

LB - 010 LOT: EXP:

Peel Corner to Read Complete Drug Facts and Information

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


Advanced Ingredient Data


Raw Label Data

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