Equate™ Maximum Strength Mucus Relief Cold, Flu And Sore Throat 9fl Oz

Equate™ Maximum Strength Mucus Relief Cold, Flu And Sore Throat 9fl Oz
SPL v8
SPL
SPL Set ID 2fd5be4f-2bb6-4241-9e0f-be7610ae2fdc
Route
ORAL
Published
Effective Date 2025-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) 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 Potassium Citrate Propylene Glycol Propyl Gallate Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-09-06

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • sinus congestion and pressure
    • cough due to minor throat and bronchial irritation
    • minor aches and pains
    • sore throat
    • headache
  • temporarily reduces fever
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

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

Section 55105-1
Active ingredients (in each 20 mL) Purposes

Acetaminophen 650 mg

Pain reliever/fever reducer

Dextromethorphan HBr 20 mg

Cough suppressant

Guaifenesin 400 mg

Expectorant

Phenylephrine HCl 10 mg

Nasal decongestant

Directions
  • do not take more than directed (see Overdose Warning) )
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL= milliliter
  • Adults and children 12 years of age and older:20 mL in dosing cup provided every 4 hours
  • Children under 12 years of age:Do not use
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.
  • 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.
Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
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 (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you don’t notice any signs or symptoms.

Other Information
  • each 20 mL contains: sodium 8 mg
  • store between 15-30°C (59-86°F)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-888-287-1915

Principal Display Panel

equate™

NDC 49035-771-09

Compare to Mucinex® Fast-Max® Maximum Strength Cold, Flu & Sore Throat Active Ingredients*

Maximum Strength‡

Mucus Relief

Cold, Flu & Sore Throat

Acetaminophen -Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Guaifenesin - Expectorant

Phenylephrine HCl - Nasal Decongestant

  • Relieves headache & fever
  • Helps control cough
  • Relieves nasal & chest congestion
  • Thins & loosens mucus

For Ages 12+

9FL OZ (266mL)

Tamper evident: do not use if printed seal under cap is broken or missing.

‡Maximum Strength per 4 hour dose.

Satisfaction guaranteed-Or we’ll replace it or give you your money back For questions or commentsplease call 1-888-287-1915

Distributed by: Wal-Mart Stores, Inc.,

Bentonville, AR 72716

*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex® Fast-Max® Maximum Strength Cold, Flu & Sore Throat.

 

When Using This Product
  • do not use more than directed
Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse, or lasts more than 7 days
  • fever gets worse, or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash, or persistent headache.
  • These could be signs of a serious condition.
Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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

Structured Label Content

Uses
  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • sinus congestion and pressure
    • cough due to minor throat and bronchial irritation
    • minor aches and pains
    • sore throat
    • headache
  • temporarily reduces fever
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each 20 mL) Purposes

Acetaminophen 650 mg

Pain reliever/fever reducer

Dextromethorphan HBr 20 mg

Cough suppressant

Guaifenesin 400 mg

Expectorant

Phenylephrine HCl 10 mg

Nasal decongestant

Directions
  • do not take more than directed (see Overdose Warning) )
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL= milliliter
  • Adults and children 12 years of age and older:20 mL in dosing cup provided every 4 hours
  • Children under 12 years of age:Do not use
Do Not Use (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.
  • 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.
Liver Warning: (Liver warning:)

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product
Overdose Warning (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 (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you don’t notice any signs or symptoms.

Other Information (Other information)
  • each 20 mL contains: sodium 8 mg
  • store between 15-30°C (59-86°F)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-888-287-1915

Principal Display Panel

equate™

NDC 49035-771-09

Compare to Mucinex® Fast-Max® Maximum Strength Cold, Flu & Sore Throat Active Ingredients*

Maximum Strength‡

Mucus Relief

Cold, Flu & Sore Throat

Acetaminophen -Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Guaifenesin - Expectorant

Phenylephrine HCl - Nasal Decongestant

  • Relieves headache & fever
  • Helps control cough
  • Relieves nasal & chest congestion
  • Thins & loosens mucus

For Ages 12+

9FL OZ (266mL)

Tamper evident: do not use if printed seal under cap is broken or missing.

‡Maximum Strength per 4 hour dose.

Satisfaction guaranteed-Or we’ll replace it or give you your money back For questions or commentsplease call 1-888-287-1915

Distributed by: Wal-Mart Stores, Inc.,

Bentonville, AR 72716

*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex® Fast-Max® Maximum Strength Cold, Flu & Sore Throat.

 

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
  • pain, nasal congestion, or cough gets worse, or lasts more than 7 days
  • fever gets worse, or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash, or persistent headache.
  • These could be signs of a serious condition.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)
  • you are taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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