MENSTRUAL COMPLETE MAXIMUM STRENGTH- acetaminophen, caffeine and pyrilamine maleate tablet, film coated
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 44-390

Active ingredients (in each caplet)

Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg

Purpose

Pain reliever
Diuretic
Antihistamine

Uses

for the temporary relief of these symptoms associated with menstrual periods:
- bloating
- headache
- water-weight gain
- cramps
- backache
- breast tenderness
- fatigue
- muscle aches

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take:

more than 6 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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

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

When using this product

you may get drowsy
avoid alcoholic drinks
excitability may occur, especially in children
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Stop use and ask a doctor if

new symptoms occur
redness or swelling is present
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days

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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than the recommended dose (see overdose warning)
adults and children 12 years and older:
- take 2 caplets with water
- repeat every 6 hours, as needed
- do not exceed 6 caplets per day
children under 12 years: ask a doctor

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, titanium dioxide, triacetin

Principal Display Panel

NDC 37205-738-62

LEADER®

Compare to
Midol® Complete
active ingredients*

MAXIMUM STRENGTH
M en s t r u a l C o m p l e t e

Acetaminophen, Caffeine, Pyrilamine maleate
Pain Reliever • Diuretic • Antihistamine

Multi-Symptom Relief
Cramps • Bloating • Fatigue • Backache • Headache

SATISFACTION
GUARANTEED

24 CAPLETS

*This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Midol® Complete.
50844 REV0913A39008

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
CIN 4595625

www.myleader.com 1-800-200-6313

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

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

Leader 44-390

MENSTRUAL COMPLETE MAXIMUM STRENGTH
acetaminophen, caffeine and pyrilamine maleate tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-738
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	60 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	15 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE	Score	score with uneven pieces
Shape	OVAL	Size	17mm
Flavor		Imprint Code	44;390
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37205-738-62	3 in 1 CARTON	04/29/2002	10/16/2020
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	04/29/2002	10/16/2020

Labeler - CARDINAL HEALTH (097537435)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(37205-738)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(37205-738)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(37205-738)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(37205-738)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(37205-738)

Revised: 11/2018

Document Id: 1df5beda-fc1c-4826-9c86-7d6050baf79a

Set id: 87f50836-51de-4f92-905e-b89e79afdf3e

Version: 6

Effective Time: 20181106

CARDINAL HEALTH