Maximum Strength Max Severe Congestion & Cough

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 2024-01-30

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)

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.

Indications and Usage

Uses

● helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

● temporarily relieves these symptoms occurring 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 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 9:30AM to 4:30 PM EST 1-877-798-5944

Section 55105-1

Purpose

Dextromethorphan HBr    Cough suppressant

Guaifenesin                     Expectorant

Phenylephrine                 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

Maximum Strength Max Severe Congestion & Cough

AP SAFE^® NDC 76281-517-25

Compare to Mucinex^® FAST-MAX™ Severe Congestion

& Cough Active ingredients*

Maximum Strength

Max Severe Congestion & Cough

Dextromethorphan HBr/

Cough Suppressant

Guaifenesin /Expectorant

Phenylephrine HCI / Nasal Decongestant

Congestion& Cough

Relief of:

• Cough

• Thins & Loosens Mucus

• Nasal & Chest Congestion

Adults- For Ages 12 and over

6 FL OZ ( 177 mL)

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

Manufactured by:

AptaPharma Inc.,

1533 Union Ave.

Pennsauken, NJ 08110

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 phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

● temporarily relieves these symptoms occurring 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)

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.

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 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 9:30AM to 4:30 PM EST 1-877-798-5944

Section 55105-1 (55105-1)

Purpose

Dextromethorphan HBr    Cough suppressant

Guaifenesin                     Expectorant

Phenylephrine                 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

Maximum Strength Max Severe Congestion & Cough

AP SAFE^® NDC 76281-517-25

Compare to Mucinex^® FAST-MAX™ Severe Congestion

& Cough Active ingredients*

Maximum Strength

Max Severe Congestion & Cough

Dextromethorphan HBr/

Cough Suppressant

Guaifenesin /Expectorant

Phenylephrine HCI / Nasal Decongestant

Congestion& Cough

Relief of:

• Cough

• Thins & Loosens Mucus

• Nasal & Chest Congestion

Adults- For Ages 12 and over

6 FL OZ ( 177 mL)

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

Manufactured by:

AptaPharma Inc.,

1533 Union Ave.

Pennsauken, NJ 08110

This product is not manufactured or distributed by Reckitt Benckiser Inc., distributor of Mucinex^® FAST-MAX™ Severe

Congestion & Cough.

res

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses ● helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes ● temporarily relieves these symptoms occurring with a cold: ● cough due to minor throat and bronchial irritation ● nasal congestion", "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", "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) 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.", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "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", "53413-1": "Questions? Call weekdays from 9:30AM to 4:30 PM EST 1-877-798-5944", "55105-1": "Purpose Dextromethorphan HBr Cough suppressant Guaifenesin Expectorant Phenylephrine Nasal Decongestant", "55106-9": "Drug Facts Active ingredients (in each 20 mL) Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg", "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", "Maximum Strength Max Severe Congestion & Cough": "AP SAFE ® NDC 76281-517-25 Compare to Mucinex ® FAST-MAX™ Severe Congestion & Cough Active ingredients* Maximum Strength Max Severe Congestion & Cough Dextromethorphan HBr/ Cough Suppressant Guaifenesin /Expectorant Phenylephrine HCI / Nasal Decongestant Congestion& Cough Relief of: • Cough • Thins & Loosens Mucus • Nasal & Chest Congestion Adults- For Ages 12 and over 6 FL OZ ( 177 mL) DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING Manufactured by: AptaPharma Inc., 1533 Union Ave. Pennsauken, NJ 08110 This product is not manufactured or distributed by Reckitt Benckiser Inc., distributor of Mucinex ® FAST-MAX™ Severe Congestion & Cough. res"}

Maximum Strength Max Severe Congestion & Cough

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information