Leader Extra Strength Acetaminophen Caplets, 500 mg

Acetaminophen by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACETAMINOPHEN- acetaminophen tablet 
Cardinal Health, Inc.

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 Extra Strength Acetaminophen Caplets, 500 mg

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purposes

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
• headache
• the common cold
• backache
• minor pain of arthritis
• muscular aches
• toothache
• premenstrual and menstrual cramps
• temporarily reduces fever

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.

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

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 are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

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

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: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 every 6 hours while symptoms last
• do not take more than 6 caplets in 24 hours unless directed by a doctor
• do not take for more than 10 days unless directed by a doctor
• children under 12 years: ask a doctor

Other information

• store at room temperature

Inactive ingredients

hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Questions or Comments?

call (800) 795-9775

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

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

LEADER™

Extra Strength

Acetaminophen

Caplets, 500 mg

Pain Reliever / Fever Reducer

FOR ADULTS

Aspirin Free

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0151
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	GPI;A5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0151-1	1 in 1 CARTON	11/17/2016	01/31/2020
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 70000-0151-3	1 in 1 CARTON	11/17/2016	01/31/2020
2		100 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 70000-0151-4	225 in 1 BOTTLE; Type 0: Not a Combination Product	11/17/2016	01/31/2020
4	NDC: 70000-0151-2	1 in 1 CARTON	01/16/2017	01/31/2020
4		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC: 70000-0151-5	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/16/2017	01/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	11/17/2016	01/31/2020

Labeler - Cardinal Health, Inc. (097537435)

Revised: 8/2018

Document Id: 74834e1b-0d5d-0542-e053-2991aa0aa1ef

34390-5

Set id: 410d7127-6ad0-4972-e054-00144ff88e88

Version: 5

Effective Time: 20180828

 

Cardinal Health, Inc.