Maximum Strength Max Cold & Sinus

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 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

Liver warning

This product contains acetaminophen.

Severe liver damage may occur if you take:

• more than 4,000 mg of acetaminophen in 24 hours

• with other drugs containing acetaminophen

• 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening

• blisters

• rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or

vomiting, consult a doctor promptly.

Do not use.

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug

contains acetaminophen, ask a doctor or pharmacist.

• 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

• liver disease

• heart disease

• thyroid disease

• high blood pressure

• diabetes

• trouble urinating due to an enlarged prostate gland

• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or emphysema

• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin.

When using this product • do not use more than directed

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur

• redness or swelling is present

• symptoms do not get better within 7 days or are accompanied by a fever

• fever gets worse or lasts more than 3 days

• new symptoms occur

• cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a

serious condition.

Indications and Usage

Uses

temporarily relieves these common cold and flu symptoms:

• nasal congestion

• sinus congestion and pressure

• minor aches and pains

• sore throat

• headache

• fever

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

Dosage and Administration

Directions

• take only as recommended (see Overdose warning)

• 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) Acetaminophen 650 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Section 34088-5

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or

contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if

you do not notice any signs or symptoms.

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 53414-9

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

Section 55105-1

Purpose

Acetaminophen        Pain reliever/Fever reducer

Guaifenesin             Expectorant

Phenylephrine HCl    Nasal decongestant

Section 55106-9

Drug Facts

Active ingredients

(in each 20 mL)

Acetaminophen 650 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 IS-30°C (59-86°F)

• do not refrigerate

Maximum Strength Max Cold & Sinus

AP SAFE NDC 76281-515-25

Compare to Mucinex^® FAST-MAX™ Cold & Sinus

Active ingredients*

Maximum Strength

MAX COLD & SINUS

Acetaminophen /

Pain reliever/Fever Reducer

Guaifenesin /Expectorant

Phenylephrine HCl / Nasal decongestant

Cold & Sinus

Relief of:

• Fever & Bodyaches

• 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

Failure to follow these warnings could result in serious consequences.

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™ Cold &

Sinus.

res

Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves these common cold and flu symptoms:

• nasal congestion

• sinus congestion and pressure

• minor aches and pains

• sore throat

• headache

• fever

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

Dosage and Administration (34068-7)

Directions

• take only as recommended (see Overdose warning)

• 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

Liver warning

This product contains acetaminophen.

Severe liver damage may occur if you take:

• more than 4,000 mg of acetaminophen in 24 hours

• with other drugs containing acetaminophen

• 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening

• blisters

• rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or

vomiting, consult a doctor promptly.

Do not use.

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug

contains acetaminophen, ask a doctor or pharmacist.

• 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

• liver disease

• heart disease

• thyroid disease

• high blood pressure

• diabetes

• trouble urinating due to an enlarged prostate gland

• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or emphysema

• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin.

When using this product • do not use more than directed

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur

• redness or swelling is present

• symptoms do not get better within 7 days or are accompanied by a fever

• fever gets worse or lasts more than 3 days

• new symptoms occur

• cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a

serious condition.

Section 34088-5 (34088-5)

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or

contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if

you do not notice any signs or symptoms.

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 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Acetaminophen        Pain reliever/Fever reducer

Guaifenesin             Expectorant

Phenylephrine HCl    Nasal decongestant

Section 55106-9 (55106-9)

Drug Facts

Active ingredients

(in each 20 mL)

Acetaminophen 650 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 IS-30°C (59-86°F)

• do not refrigerate

Maximum Strength Max Cold & Sinus (Maximum Strength MAX COLD & SINUS)

AP SAFE NDC 76281-515-25

Compare to Mucinex^® FAST-MAX™ Cold & Sinus

Active ingredients*

Maximum Strength

MAX COLD & SINUS

Acetaminophen /

Pain reliever/Fever Reducer

Guaifenesin /Expectorant

Phenylephrine HCl / Nasal decongestant

Cold & Sinus

Relief of:

• Fever & Bodyaches

• 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

Failure to follow these warnings could result in serious consequences.

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™ Cold &

Sinus.

res

Advanced Ingredient Data

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "650", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYL GALLATE", "unii": "8D4SNN7V92", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses temporarily relieves these common cold and flu symptoms : • nasal congestion • sinus congestion and pressure • minor aches and pains • sore throat • headache • fever • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes", "34068-7": "Directions • take only as recommended (see Overdose warning) • 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 Liver warning This product contains acetaminophen. Severe liver damage may occur if you take: • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. Do not use. • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • 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 • liver disease • heart disease • thyroid disease • high blood pressure • diabetes • trouble urinating due to an enlarged prostate gland • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or emphysema • cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin. When using this product • do not use more than directed Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occur • redness or swelling is present • symptoms do not get better within 7 days or are accompanied by a fever • fever gets worse or lasts more than 3 days • new symptoms occur • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.", "34088-5": "Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "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", "53414-9": "If pregnant or breast feeding, ask a health professional before use.", "55105-1": "Purpose Acetaminophen Pain reliever/Fever reducer Guaifenesin Expectorant Phenylephrine HCl Nasal decongestant", "55106-9": "Drug Facts Active ingredients (in each 20 mL) Acetaminophen 650 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg", "60561-8": "Other information • each 20 mL contains: sodium 10 mg • dosage cup provided • store between IS-30°C (59-86°F) • do not refrigerate", "Maximum Strength MAX COLD & SINUS": "AP SAFE NDC 76281-515-25 Compare to Mucinex ® FAST-MAX™ Cold & Sinus Active ingredients* Maximum Strength MAX COLD & SINUS Acetaminophen / Pain reliever/Fever Reducer Guaifenesin /Expectorant Phenylephrine HCl / Nasal decongestant Cold & Sinus Relief of: • Fever & Bodyaches • 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 Failure to follow these warnings could result in serious consequences. 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™ Cold & Sinus. res"}

Maximum Strength Max Cold & Sinus

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information