EXTRA STRENGTH PAIN RELIEVER PM- acetaminophen and diphenhydramine hcl 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.

----------

Leader 44-235-Delisted

Active ingredients (in each caplet)

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Purpose

Pain reliever
Nighttime sleep-aid

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings

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

more than 4,000 mg of acetaminophen in 24 hours
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.
with any other product containing diphenhydramine, even one used on skin
in children under 12 years of age
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

liver disease
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
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

drowsiness will occur
avoid alcoholic beverages
do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
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 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 directed (see overdose warning)
adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

NDC 37205-759-71

Compare to Extra Strength Tylenol® PM active ingredients*

LEADER®

EXTRA STRENGTH
Pain Reliever PM
Acetaminophen 500 mg, Diphenhydramine HCl 25 mg
Pain Reliever/Nighttime Sleep-Aid
Non-habit forming

50 CAPLETS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM.
50844 ORG051223515

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
CIN 4760310
www.myleader.com
1-800-200-6313

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

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Leader 44-235

EXTRA STRENGTH PAIN RELIEVER PM
acetaminophen and diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-759
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	44;235
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37205-759-71	1 in 1 CARTON	05/15/1994	04/08/2022
1		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:37205-759-78	1 in 1 CARTON	05/15/1994	11/07/2019
2		100 in 1 BOTTLE, PLASTIC; 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	05/15/1994	04/08/2022

Labeler - Cardinal Health (097537435)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(37205-759)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(37205-759) , pack(37205-759)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(37205-759)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(37205-759)

Revised: 1/2023

Document Id: 81d23a9f-0eb4-42fc-a652-e71e902a2a3d

Set id: d09db275-8e25-434e-80d1-e1c8c2ef4389

Version: 10

Effective Time: 20230126

Cardinal Health