Leader Premenstrual

Dosage form: capsule
Ingredients: ACETAMINOPHEN 500mg, PAMABROM 25mg, PYRILAMINE MALEATE 15mg
Labeler: Cardinal Health
NDC Code: 37205-339

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.

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:

  • cramps
  • bloating
  • breast tenderness

Warnings

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

  • more than 4 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product
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
  • do not take more than the recommended dose (see Overdose warning)
  • adults and children 12 years of age and older: take 2 caplets with water
  • repeat every 6 hours, as needed
  • do not exceed 8 caplets per day
  • children under 12 years of age: consult a doctor


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 
acetaminophen, pamabrom, pyrilamine maleate capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-339
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
PAMABROM (PAMABROM) PAMABROM25 mg
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE15 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
MAGNESIUM SILICATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
Colorwhite (WHITE) Scoreno score
ShapeOVAL (OVAL) Size7mm
FlavorImprint CodeCPC2826
Contains    
Packaging
#Item CodePackage Description
1NDC:37205-339-6224 CAPSULE (CAPSULE) 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: 02/2012
 
Cardinal Health

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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