PAIN RELIEVER EXTRA STRENGTH- acetaminophen capsule, liquid filled

pain reliever by

Drug Labeling and Warnings

pain reliever by is a Otc medication manufactured, distributed, or labeled by Cardinal Health (Leader) 70000. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each capsule)

Acetaminophen 500 mg

Purpose

Pain reliever/ fever reducer

Uses

• temporarily relieves minor aches and pains due to

• headache
• the common cold
• backache
• minor pain of arthritis
• toothache
• muscular aches
• 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 (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 6 capsules in any 24-hour period
• do not take more than directed (see Overdose warning)
• adults and children 12 years and over
  • take 2 capsules every 6 hours while symptoms  last
  • do not take more than 10 days unless directed by a doctor
• children under 12 years: do not use

Other information

• each capsule contains: sodium 9 mg
• store between 15-30ºC (59-86ºF)

Inactive ingredients

FD&C red #40, gelatin, glycerin, polyethylene glycol, potassium hydroxide, povidone, propylene glycol, purified water,sodium hydroxide, sorbitan, sorbitol, titanium dioxide

Questions or comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Extra Strength

Acetaminophen

500 mg | Pain Reliever / Fever Reducer

FOR ADULTS

Alcohol Free

SOFTGELS*

(*Liquid-Filled Capsules)

COMPARE TO TYLENOL® EXTRA STRENGTH active ingredient**

**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Extra Strength.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

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

Product Label

LEADER Extra Strength Acetaminophen Softgels

INGREDIENTS AND APPEARANCE

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0137
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
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE (UNII: FZ989GH94E)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	YELLOW	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	710
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0137-1	1 in 1 BOX	10/31/2016	12/31/2021
1		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 70000-0137-2	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/31/2016	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	10/31/2016	12/31/2021

Labeler - Cardinal Health (Leader) 70000 (097537435)