Leader 44-679

Leader 44-679
SPL v14
SPL
SPL Set ID 8df6e174-8ee3-46cc-98ef-2b9a801b7b78
Route
ORAL
Published
Effective Date 2025-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Bromotheophylline (25 mg) Pyrilamine (15 mg)
Inactive Ingredients
Starch, Corn Croscarmellose Sodium Crospovidone, Unspecified Fd&c Blue No. 2 Aluminum Lake Fd&c Red No. 40 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Shellac Silicon Dioxide Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;679 Shape: oval Color: purple Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-01-13

Description

Acetaminophen 500 mg Pamabrom 25 mg Pyrilamine maleate 15 mg

Purpose

Pain reliever Diuretic Antihistamine 


Medication Information

Purpose

Pain reliever

Diuretic

Antihistamine 

Description

Acetaminophen 500 mg Pamabrom 25 mg Pyrilamine maleate 15 mg

Uses

for the temporary relief of these symptoms associated with menstrual periods:

  • headache
  • bloating
  • cramps
  • backache
  • muscular aches
  • irritability
  • water-weight gain 
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. 

Directions
  • do not take more than directed

  • adults and children 12 years and over:
    • take 2 caplets with water every 6 hours as needed
    • do not exceed 6 caplets in a 24 hour period or as directed by a doctor
  • 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 have ever had an allergic reaction to this product or any of its ingredients 
Other Information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 
Inactive Ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, shellac wax, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-800-426-9391

Principal Display Panel

LEADER™

NDC 70000-0145-1

Maximum Strength Multi-Symptom

Menstrual Relief

Acetaminophen | Pamabrom | Pyrilamine maleate

Pain Reliever | Diuretic | Antihistamine

Relieves:

Cramps, Bloating, Irritability,

Headache and Backache

20 CAPLETS

ACTUAL SIZE

COMPARE TO MAXIMUM STRENGTH

PAMPRIN® MULTI-SYMPTOM

active ingredients*

100% Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

Focus Consumer Healthcare, LLC, owner of the

registered trademark Maximum Strength Pamprin®

Multi-Symptom.       50844        REV0718B67909

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

©2024 Cardinal Health. All Rights Reserved.

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.

100%

Money Back

Guarantee

Return to place of purchase.

Leader 44-679
When Using This Product
  • drowsiness may occur

  • avoid alcoholic beverages
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery 
Stop Use and Ask A Doctor If
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

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 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg

Ask A Doctor Before Use If You Have
  • difficulty in urination due to enlargement of the prostate gland
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis 
  • glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers 

Structured Label Content

Uses

for the temporary relief of these symptoms associated with menstrual periods:

  • headache
  • bloating
  • cramps
  • backache
  • muscular aches
  • irritability
  • water-weight gain 
Purpose

Pain reliever

Diuretic

Antihistamine 

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. 

Directions
  • do not take more than directed

  • adults and children 12 years and over:
    • take 2 caplets with water every 6 hours as needed
    • do not exceed 6 caplets in a 24 hour period or as directed by a doctor
  • 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 have ever had an allergic reaction to this product or any of its ingredients 
Other Information (Other information)
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 
Inactive Ingredients (Inactive ingredients)

corn starch, croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, shellac wax, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

LEADER™

NDC 70000-0145-1

Maximum Strength Multi-Symptom

Menstrual Relief

Acetaminophen | Pamabrom | Pyrilamine maleate

Pain Reliever | Diuretic | Antihistamine

Relieves:

Cramps, Bloating, Irritability,

Headache and Backache

20 CAPLETS

ACTUAL SIZE

COMPARE TO MAXIMUM STRENGTH

PAMPRIN® MULTI-SYMPTOM

active ingredients*

100% Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

Focus Consumer Healthcare, LLC, owner of the

registered trademark Maximum Strength Pamprin®

Multi-Symptom.       50844        REV0718B67909

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

©2024 Cardinal Health. All Rights Reserved.

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.

100%

Money Back

Guarantee

Return to place of purchase.

Leader 44-679
When Using This Product (When using this product)
  • drowsiness may occur

  • avoid alcoholic beverages
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • 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 gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

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 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 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
  • a breathing problem such as emphysema or chronic bronchitis 
  • glaucoma
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

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