best Choice ​

 best Choice ​
SPL v1
SPL
SPL Set ID 8c878e47-94f4-484f-bdd8-6d87ac2440d8
Route
ORAL
Published
Effective Date 2025-01-28
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 2025-01-01

Description

Drug Facts Active ingredients (in each 20 mL) Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg


Medication Information

Warnings and Precautions

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.

■ for children under 12 years of age.

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)

Indications and Usage

Uses

■ helps loosen pjlegm (mucus)

and thin bronchial secretions

to drain bronchial tubes

■ Temporarily relieves these symptoms ocurring with a cold:

      ■ cough due to minor throat and bronchial irritation

      ■ nasal congestion

Dosage and Administration

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 & children 12 years and older  20 mL every 4 hours              
 Children under 12 years of age  Do not use

Description

Drug Facts Active ingredients (in each 20 mL) Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get

medical help or contact a Poison Control Center right

away.

Section 50566-9

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.

Section 50567-7

When using this product, do not use

more than directed

Section 51727-6

Inactive ingredients

anhydrous citric acid, edetate

disodium, FD&C Blue #1, FD&C Red

#40, flavors, glycerin, propylene

glycol, propyl gallate, purified water,

sodium benzoate, sorbitol, sucralose,

xanthan gum

Section 53413-1

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

Section 53414-9

If pregnant or breast feeding ask a health professional before use.

Section 55105-1

Purpose

Dextromethorphan HBr ..........Cough suppressant

Guaifenesin ...........................Expectorant

Phenylephrine HCl ................. Nasal Decongestant

Section 55106-9

Drug Facts

Active ingredients

(in each 20 mL)



Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Section 60561-8

Other information

Each 20 mL contains: sodium 10 mg

■ dosage cup provided

■ store between 15-30° C (59-86° F)

■ do not refrigerate

Product Label: Best Choice® Max Severe Congestion & Cough

Best Choice®

MAXIMUM STRENGTH

Max Severe Congestion & Cough

6 FL OZ (177 mL)

PROUDLY DISTRIBUTED BY:

VALUE MERCHANDISERS, CO.

5000 KANSAS AVE

KANSAS CITY, KS 66106

Compare to the active ingredients in

Mucinex® FAST-MAX™ Severe

Congestion & Cough*

*This product is not manufactured or

distributed by Reckitt Benckiser Inc.,

distributor of Mucinex® FAST-MAX™

Severe Congestion & Cough*

res


Structured Label Content

Indications and Usage (34067-9)

Uses

■ helps loosen pjlegm (mucus)

and thin bronchial secretions

to drain bronchial tubes

■ Temporarily relieves these symptoms ocurring with a cold:

      ■ cough due to minor throat and bronchial irritation

      ■ nasal congestion

Dosage and Administration (34068-7)

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 & children 12 years and older  20 mL every 4 hours              
 Children under 12 years of age  Do not use

Warnings and Precautions (34071-1)

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.

■ for children under 12 years of age.

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)

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get

medical help or contact a Poison Control Center right

away.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product, do not use

more than directed

Section 51727-6 (51727-6)

Inactive ingredients

anhydrous citric acid, edetate

disodium, FD&C Blue #1, FD&C Red

#40, flavors, glycerin, propylene

glycol, propyl gallate, purified water,

sodium benzoate, sorbitol, sucralose,

xanthan gum

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

If pregnant or breast feeding ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Dextromethorphan HBr ..........Cough suppressant

Guaifenesin ...........................Expectorant

Phenylephrine HCl ................. Nasal Decongestant

Section 55106-9 (55106-9)

Drug Facts

Active ingredients

(in each 20 mL)



Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Section 60561-8 (60561-8)

Other information

Each 20 mL contains: sodium 10 mg

■ dosage cup provided

■ store between 15-30° C (59-86° F)

■ do not refrigerate

(-----------)

Product Label: Best Choice® Max Severe Congestion & Cough

Best Choice®

MAXIMUM STRENGTH

Max Severe Congestion & Cough

6 FL OZ (177 mL)

PROUDLY DISTRIBUTED BY:

VALUE MERCHANDISERS, CO.

5000 KANSAS AVE

KANSAS CITY, KS 66106

Compare to the active ingredients in

Mucinex® FAST-MAX™ Severe

Congestion & Cough*

*This product is not manufactured or

distributed by Reckitt Benckiser Inc.,

distributor of Mucinex® FAST-MAX™

Severe Congestion & Cough*

res


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