Quality Choice 44-738

Quality Choice 44-738
SPL v8
SPL
SPL Set ID 7d1b3418-85a8-4ca0-bca7-261b2b58032a
Route
ORAL
Published
Effective Date 2025-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Chlorpheniramine (2 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Starch, Corn Crospovidone, Unspecified Fd&c Red No. 40 Aluminum Lake Lecithin, Soybean Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Silicon Dioxide Sodium Starch Glycolate Type A Potato Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;738 Shape: oval Color: red Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-25

Description

Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Dextromethorphan HBr 10 mg

Purpose

Pain reliever/fever reducer Antihistamine Cough suppressant


Medication Information

Purpose

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Description

Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Dextromethorphan HBr 10 mg

Uses
  • temporarily relieves these common cold and flu symptoms:
    • minor aches and pains
    • sore throat

    • sneezing
    • headache
    • runny nose
    • cough
  • 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:

  • 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

  • adults and children 12 years and over: take 2 caplets every 4 hours while symptoms persist. 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Other Information
  • 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
  • protect from excessive moisture

Inactive Ingredients

corn starch, crospovidone, FD&C red #40 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-800-426-9391

Principal Display Panel

QC®

QUALITY

CHOICE

NDC 63868-567-20

*Compare to the active ingredients in

Coricidin® HBP Maximum Strength

Multi-Symptom Flu

Maximum Strength

Flu HBP

For People with High Blood Pressure

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Pain Reliever/Fever Reducer,

Antihistamine & Cough Suppressant

Decongestant-Free

Relieves: Body Aches,

Pains and Headache,

Fever, Cough, Runny Nose,

Sore Throat, and Sneezing

20 Caplets

actual size

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 Bayer

HealthCare LLC, owner of the registered trademark

Coricidin® HBP Maximum Strength Multi-Symptom Flu.

50844 REV1019A73809

Distributed by CDMA, Inc.

43157 W Nine Mile

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

SATISFACTION GUARANTEED 

100% QC

Quality Choice 44-738
When Using This Product
  • avoid alcoholic beverages
  • marked drowsiness may occur

  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • use caution when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If
  • pain 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 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 Caplet)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Ask A Doctor Before Use If You Have
  • difficulty in urination due to enlargement of the prostate gland

  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • glaucoma
  • a breathing problem or persistent or chronic cough 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
  • taking sedatives or tranquilizers

Structured Label Content

Uses
  • temporarily relieves these common cold and flu symptoms:
    • minor aches and pains
    • sore throat

    • sneezing
    • headache
    • runny nose
    • cough
  • temporarily reduces fever
Purpose

Pain reliever/fever reducer

Antihistamine

Cough suppressant

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

  • adults and children 12 years and over: take 2 caplets every 4 hours while symptoms persist. 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Other Information (Other information)
  • 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
  • protect from excessive moisture

Inactive Ingredients (Inactive ingredients)

corn starch, crospovidone, FD&C red #40 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

QC®

QUALITY

CHOICE

NDC 63868-567-20

*Compare to the active ingredients in

Coricidin® HBP Maximum Strength

Multi-Symptom Flu

Maximum Strength

Flu HBP

For People with High Blood Pressure

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Pain Reliever/Fever Reducer,

Antihistamine & Cough Suppressant

Decongestant-Free

Relieves: Body Aches,

Pains and Headache,

Fever, Cough, Runny Nose,

Sore Throat, and Sneezing

20 Caplets

actual size

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 Bayer

HealthCare LLC, owner of the registered trademark

Coricidin® HBP Maximum Strength Multi-Symptom Flu.

50844 REV1019A73809

Distributed by CDMA, Inc.

43157 W Nine Mile

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

SATISFACTION GUARANTEED 

100% QC

Quality Choice 44-738
When Using This Product (When using this product)
  • avoid alcoholic beverages
  • marked drowsiness may occur

  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • use caution when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain 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 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 Caplet) (Active ingredients (in each caplet))

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • difficulty in urination due to enlargement of the prostate gland

  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • glaucoma
  • a breathing problem or persistent or chronic cough 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
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)