SPL v7
SPL
SPL Set ID f17385bc-82bb-4183-a4c9-067d8afb3757
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) Phenylephrine (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Propyl Gallate Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

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

Description

Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 mg Phenylephrine HCL, USP 10 mg

Purpose

Cough Suppressant Expectorant Naasal Decongestant


Medication Information

Purpose

Cough Suppressant

Expectorant

Naasal Decongestant

Description

Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 mg Phenylephrine HCL, USP 10 mg

Uses
  • help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occuring with a cold:
  • cough due to minor throat and bronchial irritation
  • nasal congestion
Warnings

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 = milliliter
  • do not take more than 6 doses in any 24-hour period
 Age  Dose
 Adults and children 12 years and older  20 mL every 4 hours
 Children under 12 years of age  Do not use

Drug Facts

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Phenylephrine HCL, USP 10 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 10 mg
  • dosage cup provided
  • store between 15°-30°C (59°-86°F)
  • do not refrigerate
Inactive Ingredients

Anhydrous citric acid, edetate disodium, FD and C Blue # 1, FD and Red # 40, glycerin, flavors, glycerin, , propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, Xanthan gum

When Using This Product
  • do not use more than directed
Stop Use and Ask A Doctor If
  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or are accompanied by a fever
  • Cough comes back, or occurs with fever, rash or persistent 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 Use If You Have
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • 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 Severe Congestion & Cough Max Product Label

*COMPARE TO THE ACTIVE INGREDIENTS IN MUCINEX® FAST-MAX™ SEVERE CONGESTION AND COUGH

LF-011

DISCOUNT

drug mart

FOOD FAIR

MAXIUM STRENGTH SEVERE CONGESTION & COUGH MAX

Dextromethorphan HBr/ Guaifenesin / Phenylephrine HCL

COUGH SUPPRESSANT/

EXPECTORANT/

NASAL DECONGESTANT

Controls Cough

Thins & Loosens mucus

Relieves Nasal & 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™ SEVERE CONGESTION AND COUGH

LB - 011 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
  • help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occuring with a cold:
  • cough due to minor throat and bronchial irritation
  • nasal congestion
Purpose

Cough Suppressant

Expectorant

Naasal Decongestant

Warnings

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 = milliliter
  • do not take more than 6 doses in any 24-hour period
 Age  Dose
 Adults and children 12 years and older  20 mL every 4 hours
 Children under 12 years of age  Do not use

Drug Facts

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Phenylephrine HCL, USP 10 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 10 mg
  • dosage cup provided
  • store between 15°-30°C (59°-86°F)
  • do not refrigerate
Inactive Ingredients (Inactive ingredients)

Anhydrous citric acid, edetate disodium, FD and C Blue # 1, FD and Red # 40, glycerin, flavors, glycerin, , propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, 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)
  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or are accompanied by a fever
  • Cough comes back, or occurs with 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.

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)
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • 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 Severe Congestion & Cough Max Product Label (DISCOUNT drug mart FOOD FAIR MAXIUM STRENGTH SEVERE CONGESTION & COUGH MAX product label)

*COMPARE TO THE ACTIVE INGREDIENTS IN MUCINEX® FAST-MAX™ SEVERE CONGESTION AND COUGH

LF-011

DISCOUNT

drug mart

FOOD FAIR

MAXIUM STRENGTH SEVERE CONGESTION & COUGH MAX

Dextromethorphan HBr/ Guaifenesin / Phenylephrine HCL

COUGH SUPPRESSANT/

EXPECTORANT/

NASAL DECONGESTANT

Controls Cough

Thins & Loosens mucus

Relieves Nasal & 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™ SEVERE CONGESTION AND COUGH

LB - 011 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


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Raw Label Data

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