Quality Plus 44-005

Quality Plus 44-005
SPL v13
SPL
SPL Set ID 1876f1db-1a82-4692-8d29-a4b764064c80
Route
ORAL
Published
Effective Date 2025-02-15
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 Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Trisodium Citrate Dihydrate Sodium Metabisulfite Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-03-01

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 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 Guaifenesin 400 mg Phenylephrine HCl 10 mg

Uses
  • temporarily relieves these common cold and flu symptoms:

    • minor aches and pains

    • sinus congestion and pressure

    • cough due to minor throat and bronchial irritation
    • headache

    • nasal congestion
    • sore throat

  • temporarily promotes nasal and/or sinus drainage
  • temporarily reduces fever

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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:

  • blisters
  • rash

  • skin reddening

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
  • do not take more than directed

  • do not take more than 6 doses in any 24-hour period

  • mL = milliliter; FL OZ = fluid ounce

  • only use the dose cup provided
  • adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours

  • children under 12 years: 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.
  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Other Information
  • each 20 mL contains: sodium 10 mg

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • use by expiration date on package
Inactive Ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose

Questions Or Comments?

  1-800-426-9391

Principal Display Panel

QUALITY

+PLUS

NDC 50844-005-45

*Compare to active ingredients

in Mucinex® FAST-MAX®

Cold, Flu & Sore Throat

MAXIMUM STRENGTH

COLD, FLU &

SORE THROAT

  Acetaminophen

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl

Pain Reliever/

Fever Reducer

Cough Suppressant

Expectorant

Nasal Decongestant

Mixed

Berry

Flavored 

6 FL OZ (177 mL)

F-005-45

REV B

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

*This product is not manufactured or distributed

by RB Health (US) LLC, owner of the registered

trademark Mucinex® FAST-MAX® Cold, Flu &

Sore Throat.

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive

Hauppauge, NY 11788

USA

50844       REV0621B00545

Quality Plus 44-005
When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • new symptoms occur

  • nervousness, dizziness, or sleeplessness occur

  • fever gets worse or lasts more than 3 days

  • redness or swelling is present

  • cough comes back or occurs with rash or headache that lasts. 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.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each 20 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have
  • cough that occurs with too much phlegm (mucus)
  • liver disease
  • thyroid disease
  • heart disease
  • difficulty in urination due to enlargement of the prostate gland
  • high blood pressure
  • diabetes
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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:

    • minor aches and pains

    • sinus congestion and pressure

    • cough due to minor throat and bronchial irritation
    • headache

    • nasal congestion
    • sore throat

  • temporarily promotes nasal and/or sinus drainage
  • temporarily reduces fever

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

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:

  • blisters
  • rash

  • skin reddening

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
  • do not take more than directed

  • do not take more than 6 doses in any 24-hour period

  • mL = milliliter; FL OZ = fluid ounce

  • only use the dose cup provided
  • adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours

  • children under 12 years: 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.
  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Other Information (Other information)
  • each 20 mL contains: sodium 10 mg

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • use by expiration date on package
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose

Questions Or Comments? (Questions or comments?)

  1-800-426-9391

Principal Display Panel

QUALITY

+PLUS

NDC 50844-005-45

*Compare to active ingredients

in Mucinex® FAST-MAX®

Cold, Flu & Sore Throat

MAXIMUM STRENGTH

COLD, FLU &

SORE THROAT

  Acetaminophen

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl

Pain Reliever/

Fever Reducer

Cough Suppressant

Expectorant

Nasal Decongestant

Mixed

Berry

Flavored 

6 FL OZ (177 mL)

F-005-45

REV B

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

*This product is not manufactured or distributed

by RB Health (US) LLC, owner of the registered

trademark Mucinex® FAST-MAX® Cold, Flu &

Sore Throat.

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive

Hauppauge, NY 11788

USA

50844       REV0621B00545

Quality Plus 44-005
When Using This Product (When using this product)

do not exceed recommended dosage.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • new symptoms occur

  • nervousness, dizziness, or sleeplessness occur

  • fever gets worse or lasts more than 3 days

  • redness or swelling is present

  • cough comes back or occurs with rash or headache that lasts. 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.)

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 mL))

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • cough that occurs with too much phlegm (mucus)
  • liver disease
  • thyroid disease
  • heart disease
  • difficulty in urination due to enlargement of the prostate gland
  • high blood pressure
  • diabetes
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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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