LEADER PREMENSTRUAL - acetaminophen, pamabrom, pyrilamine maleate capsule 
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Leader Maximum Strength Premenstrual Relief

Active Ingredients (in each caplet)

Acetaminophen 500mg
Pamabrom 25mg
Pyrilamine Maleate 15mg

Purpose

Pain Reliever
Diuretic
Antihistimine/Diuretic

Uses

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems. 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 children even if you do not notice any signs or symptoms. Do not exceed recommended dose.

Do not use

  • with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, as a doctor or pharmacist.

As a doctor before use if you have

  • liver disease
  • glaucoma
  • difficulty in urination due to an enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis.

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

  • you may get drowsy
  • excitability may occur especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days

Pregnant or breast-feeding

ask a health professional before use

Keep out of reach of children.

Directions


Other information

store at 15-30degreesC (59-86degreesF)

Inactive Ingredients

croscarmellose sodium, hypromellose, magnesium silicate, magnesium stearate, microcrystalline celulose, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide, and triacetin.

Questions or comments?

Call toll free 1-800-200-6313

Package labeling

SEE NEW WARNINGS INFORMATION      NDC 37205-339-62

Leader Maximum Strength Premenstrual Relief

Acetaminophen

Pamabrom, Pyrilamine Maleate

Relieves: Cramps, Bloating, Tenderness

24 caplets


Distributed By Cardinal Health
Dublin, Ohio 43017
CIN 3468287
www.myleader.com 1-800-200-6313

All Leader brand products are 100% satisfaction guaranteed or return to place of purchase for full refund.


Leader Premenstrual



Leader Premenstrual

LEADER PREMENSTRUAL 
acetaminophen, pamabrom, pyrilamine maleate capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-339
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
PAMABROM (UNII: UA8U0KJM72) (PAMABROM - UNII:UA8U0KJM72) PAMABROM25 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
Colorwhite (WHITE) Scoreno score
ShapeOVAL (OVAL) Size7mm
FlavorImprint Code CPC2826
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-339-6224 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/28/2012
Labeler - Cardinal Health (097537435)

Revised: 2/2012
Document Id: 3c5b53ff-23e7-4a88-bb2e-a80111e7e359
Set id: 2e5703f9-0e6d-4853-b8bf-eca7e4feb282
Version: 2
Effective Time: 20120229
 
Cardinal Health