Leader 44-738

Leader 44-738
SPL v8
SPL
SPL Set ID ba174fcc-da1e-420c-bf9c-179ad65c2848
Route
ORAL
Published
Effective Date 2025-03-08
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 2020-06-17
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)
  • protect from excessive moisture
  • see end flap for expiration date and lot number
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?

1-800-200-6313

Principal Display Panel

LEADER™

NDC 70000-0050-1

Maximum Strength

Multi-Symptom

Flu HBP

Acetaminophen

Chlorpheniramine Maleate | Dextromethorphan HBr

Pain Reliever / Fever Reducer

Antihistamine | Cough Suppressant

Relieves:

Body Aches, Pains and Headache,

Fever, Cough, Runny Nose,

Sore Throat, Sneezing

For People with

High Blood Pressure

Decongestant-Free

COMPARE TO

CORICIDIN® HBP

MULTI-SYMPTOM FLU

MAXIMUM STRENGTH

active ingredients*

100% Money Back Guarantee

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

50844

REV1019A73809

*This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark

Coricidin® HBP Multi-Symptom Flu Maximum Strength.

©2022 Cardinal Health. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks

or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

100%

Money Back

Guarantee

Return to place of purchase.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Leader 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
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • 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 sedatives or tranquilizers
  • taking the blood thinning drug warfarin

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)
  • protect from excessive moisture
  • see end flap for expiration date and lot number
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?)

1-800-200-6313

Principal Display Panel

LEADER™

NDC 70000-0050-1

Maximum Strength

Multi-Symptom

Flu HBP

Acetaminophen

Chlorpheniramine Maleate | Dextromethorphan HBr

Pain Reliever / Fever Reducer

Antihistamine | Cough Suppressant

Relieves:

Body Aches, Pains and Headache,

Fever, Cough, Runny Nose,

Sore Throat, Sneezing

For People with

High Blood Pressure

Decongestant-Free

COMPARE TO

CORICIDIN® HBP

MULTI-SYMPTOM FLU

MAXIMUM STRENGTH

active ingredients*

100% Money Back Guarantee

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

50844

REV1019A73809

*This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark

Coricidin® HBP Multi-Symptom Flu Maximum Strength.

©2022 Cardinal Health. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks

or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

100%

Money Back

Guarantee

Return to place of purchase.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Leader 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
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • 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 sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:41.610603 · Updated: 2026-03-14T23:07:53.934759