LEADER PREMENSTRUAL- acetaminophen, pamabrom, pyrilamine maleate capsule

Leader Premenstrual by

Drug Labeling and Warnings

Leader Premenstrual by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INGREDIENTS AND APPEARANCE

LEADER PREMENSTRUAL 
acetaminophen, pamabrom, pyrilamine maleate capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-339
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
PAMABROM (UNII: UA8U0KJM72) (PAMABROM - UNII:UA8U0KJM72)	PAMABROM	25 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	15 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (WHITE)	Score	no score
Shape	OVAL (OVAL)	Size	7mm
Flavor		Imprint Code	CPC2826
Contains

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
OTC monograph not final	part343	02/28/2012

Labeler - Cardinal Health (097537435)