SPL v3
SPL
SPL Set ID d98029c0-ccd9-47e1-996f-c7786cd4ecca
Route
ORAL
Published
Effective Date 2023-12-29
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 Glycerin Propylene Glycol Propyl Gallate Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-09-19

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifensin 400 mg Phenylephrine HCL 10 mg

Purpose

Pain reliever/Fever reducer Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifensin 400 mg Phenylephrine HCL 10 mg

Uses

temporarily relieves these common cold and flu symptoms:

  • cough due to minor throat and bronchial irritation
  • 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

Warnings

Liver warning

This product contains acetaminophen. Sever 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 daily 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.

Directions
  • take only as recommended (see overdose warning)
  • use dose cup
  • mL = milliliter
  • do not take more than 6 doses in any 24-hour period

Age - Adults and children 12 years and older       Dose - 20 mL every 4 hours

Age - Children under 12 years of age                  Dose - Do not use

Do Not Use
  • with any other drugs 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
Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

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.

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 C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, Xanthan gum

When Using This Product
  • do not use more than directed
Drug Factsactive Ingredients

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifensin 400 mg

Phenylephrine HCL 10 mg

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.

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
  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • 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)

Cold , Flu & Sore Throat Product Label

"MORE FOR YOUR DOLLAR"

MARKET BASKET

*COMPARE TO THE INGREDIENTS IN MUCINEX® FAST-MAX COLD™, FLU AND SORE THROAT

Cold, Flu and Sore Throat

Maximum Strength

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorophan HBr

Cough Suppressent

Guaifenesin Expectorant

Phenylephrine HCL

Nasal Decongestant

Relieves Fever and Body Aches

Controls Cough

Thins and Loosens Mucus

Relieves Nasal and Chest Congestion

6 FL OZ (177mL)

Adults

For Ages 12 and Over

*This product is not manufactures or distributed bt Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAX™ Cold, Flu and Sore Throat.

Peel Corner to Read Complete Drug Facts and Information

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

Failure to follow these warnings could result in consequences

DISTRIBUTED BY

DEMOULAS SUPERMARKETS INC.

875 East Street

Tewksbury, MA 01876

LB-008 Rev 01

Lot:

Exp:

res

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:

  • cough due to minor throat and bronchial irritation
  • 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

Purpose

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Warnings

Liver warning

This product contains acetaminophen. Sever 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 daily 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.

Directions
  • take only as recommended (see overdose warning)
  • use dose cup
  • mL = milliliter
  • do not take more than 6 doses in any 24-hour period

Age - Adults and children 12 years and older       Dose - 20 mL every 4 hours

Age - Children under 12 years of age                  Dose - Do not use

Do Not Use (Do not use)
  • with any other drugs 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
Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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 C Red #40, 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
Drug Factsactive Ingredients (Drug FactsActive ingredients)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifensin 400 mg

Phenylephrine HCL 10 mg

Stop Use and Ask A Doctor If (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.

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)
  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • 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)

Cold , Flu & Sore Throat Product Label (Cold , Flu & Sore Throat product label)

"MORE FOR YOUR DOLLAR"

MARKET BASKET

*COMPARE TO THE INGREDIENTS IN MUCINEX® FAST-MAX COLD™, FLU AND SORE THROAT

Cold, Flu and Sore Throat

Maximum Strength

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorophan HBr

Cough Suppressent

Guaifenesin Expectorant

Phenylephrine HCL

Nasal Decongestant

Relieves Fever and Body Aches

Controls Cough

Thins and Loosens Mucus

Relieves Nasal and Chest Congestion

6 FL OZ (177mL)

Adults

For Ages 12 and Over

*This product is not manufactures or distributed bt Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAX™ Cold, Flu and Sore Throat.

Peel Corner to Read Complete Drug Facts and Information

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

Failure to follow these warnings could result in consequences

DISTRIBUTED BY

DEMOULAS SUPERMARKETS INC.

875 East Street

Tewksbury, MA 01876

LB-008 Rev 01

Lot:

Exp:

res

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin.


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Raw Label Data

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