Leader Premenstrual description, usages, side effects, indications, overdosage, supplying and lots more!

Leader Premenstrual

Cardinal Health

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Leader Maximum Strength Premenstrual Relief

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.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.


Package labeling



Package labeling

Leader Premenstrual

ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37205-339
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
PAMABROM BROMOTHEOPHYLLINE 25 mg
PYRILAMINE MALEATE PYRILAMINE 15 mg

Inactive Ingredients

Ingredient Name Strength
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

Color Size Imprint Code Shape
white (WHITE) 7 mm CPC2826 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37205-339-62 24 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2012-02-28


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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