Quality Plus 44-503a473c-08

Quality Plus 44-503a473c-08
SPL v7
SPL
SPL Set ID 6e6bae79-1231-4b74-81c1-f0c914ed4af3
Route
ORAL
Published
Effective Date 2026-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg) Chlorpheniramine (2 mg)
Inactive Ingredients
Starch, Corn Crospovidone, Unspecified D&c Yellow No. 10 Aluminum Lake Magnesium Stearate Maltodextrin Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Silicon Dioxide Sodium Starch Glycolate Type A Potato Stearic Acid Sucralose Talc Titanium Dioxide Fd&c Blue No. 1 Aluminum Lake Fd&c Blue No. 2 Aluminum Lake

Identifiers & Packaging

Pill Appearance
Imprint: 44;473 Shape: oval Color: yellow Color: blue Size: 19 mm Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-15

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 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 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Uses
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • headache
    • sore throat
    • nasal congestion
    • minor aches and pains
    • sinus congestion and pressure 
    • sneezing and runny nose (nighttime only)
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive (daytime only)
  • helps clear nasal passages
  • relieves cough to help you sleep
  • temporarily reduces fever
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.

Directions
  • do not take more than directed

  • adults and children 12 years and over

    • take 2 caplets every 4 hours

    • swallow whole – do not crush, chew, or dissolve

    • do not take more than 10 caplets in 24 hours

  • children under 12 years: ask a doctor

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.
Other Information
  • each caplet contains: sodium 3 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Questions Or Comments?

1-800-426-9391

Principal Display Panel

QUALITY

+PLUS

NDC 50844-547-08

*Compare to active ingredients in

Tylenol® COLD + FLU

SEVERE DAY & NIGHT

SEVERE

COLD & FLU

DAY

Acetaminophen,

Dextromethorphan HBr,

Guaifenesin,

Phenylephrine HCl

PAIN RELIEVER/

FEVER REDUCER,

COUGH SUPPRESSANT,

EXPECTORANT,

NASAL DECONGESTANT

ACTUAL

SIZE

16

Caplets

NIGHT

Acetaminophen,

Chlorpheniramine maleate,

Dextromethorphan HBr,

Phenylephrine HCl

PAIN RELIEVER/

FEVER REDUCER,

ANTIHISTAMINE,

COUGH SUPPRESSANT,

NASAL DECONGESTANT

ACTUAL

SIZE

8

Caplets

24 Total Caplets

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT

IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Tylenol® COLD + FLU SEVERE DAY & NIGHT.

50844               REV0825B50347308

Do Not Take Daytime and

Nighttime Products at the

Same Time.

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive

Hauppauge, NY 11788

USA

Quality plus 44-503A473C
When Using This Product
  • do not exceed recommended dosage
  • excitability may occur, especially in children (nighttime only)
  • marked drowsiness may occur (nighttime only)
  • avoid alcoholic beverages (nighttime only)
  • use caution when driving a motor vehicle or operating machinery (nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only)
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
  • new symptoms 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 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.

Do not take DAYTIME and NIGHTTIME products at the same time.

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

corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Inactive Ingredients (nighttime Only)

corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Active Ingredients (in Each Caplet) (daytime)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active Ingredients (in Each Caplet) (nighttime)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (nighttime only)

Structured Label Content

Uses
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • headache
    • sore throat
    • nasal congestion
    • minor aches and pains
    • sinus congestion and pressure 
    • sneezing and runny nose (nighttime only)
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive (daytime only)
  • helps clear nasal passages
  • relieves cough to help you sleep
  • temporarily reduces fever
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:

  • 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
  • do not take more than directed

  • adults and children 12 years and over

    • take 2 caplets every 4 hours

    • swallow whole – do not crush, chew, or dissolve

    • do not take more than 10 caplets in 24 hours

  • children under 12 years: ask a doctor

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.
Other Information (Other information)
  • each caplet contains: sodium 3 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

QUALITY

+PLUS

NDC 50844-547-08

*Compare to active ingredients in

Tylenol® COLD + FLU

SEVERE DAY & NIGHT

SEVERE

COLD & FLU

DAY

Acetaminophen,

Dextromethorphan HBr,

Guaifenesin,

Phenylephrine HCl

PAIN RELIEVER/

FEVER REDUCER,

COUGH SUPPRESSANT,

EXPECTORANT,

NASAL DECONGESTANT

ACTUAL

SIZE

16

Caplets

NIGHT

Acetaminophen,

Chlorpheniramine maleate,

Dextromethorphan HBr,

Phenylephrine HCl

PAIN RELIEVER/

FEVER REDUCER,

ANTIHISTAMINE,

COUGH SUPPRESSANT,

NASAL DECONGESTANT

ACTUAL

SIZE

8

Caplets

24 Total Caplets

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT

IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Tylenol® COLD + FLU SEVERE DAY & NIGHT.

50844               REV0825B50347308

Do Not Take Daytime and

Nighttime Products at the

Same Time.

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive

Hauppauge, NY 11788

USA

Quality plus 44-503A473C
When Using This Product (When using this product)
  • do not exceed recommended dosage
  • excitability may occur, especially in children (nighttime only)
  • marked drowsiness may occur (nighttime only)
  • avoid alcoholic beverages (nighttime only)
  • use caution when driving a motor vehicle or operating machinery (nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only)
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
  • new symptoms 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 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.

Do not take DAYTIME and NIGHTTIME products at the same time.

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

corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Inactive Ingredients (nighttime Only) (Inactive ingredients (nighttime only))

corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Active Ingredients (in Each Caplet) (daytime) (Active ingredients (in each caplet) (daytime))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active Ingredients (in Each Caplet) (nighttime) (Active ingredients (in each caplet) (nighttime))

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

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
  • taking sedatives or tranquilizers (nighttime only)

Advanced Ingredient Data


Raw Label Data

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