EQUALINE PAIN RELIEF EXTRA STRENGTH - acetaminophen capsule, coated
Supervalu 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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Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
the common cold
headache
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 8 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.

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.

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 use more than directed (see Liver warning)

adults and children 12 years and over	take 2 caplets every 6 hours as needed do not take more than 8 caplets in 24 hours
children under 12 years	do not use this adult Extra Strength 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 20º-25ºC (68º-77ºF)

Inactive ingredients

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

Questions or comments?

1-877-932-7948

Principal Display Panel

Compare to Extra Strength Tylenol® Caplets active ingredient

Extra Strength

Pain Relief

Pain Reliever/Fever Reducer

Acetaminophen, 500 mg

See New Warnings Information

Aspirin-Free

Pain Relief Carton Image 1

Pain Relief Carton Image 2

EQUALINE PAIN RELIEF EXTRA STRENGTH
acetaminophen capsule, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-917
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES
POLYETHYLENE GLYCOL
POVIDONE
STEARIC ACID

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	L917
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:41163-917-62	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		24 CAPSULE, COATED ( TABLET) in 1 BOTTLE	This package is contained within the CARTON (41163-917-62)
2	NDC:41163-917-71	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
2		50 CAPSULE, COATED ( TABLET) in 1 BOTTLE	This package is contained within the CARTON (41163-917-71)
3	NDC:41163-917-78	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
3		100 CAPSULE, COATED ( TABLET) in 1 BOTTLE	This package is contained within the CARTON (41163-917-78)
4	NDC:41163-917-90	500 CAPSULE, COATED ( TABLET) in 1 BOTTLE	None
5	NDC:41163-917-76	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
5		120 CAPSULE, COATED ( TABLET) in 1 BOTTLE	This package is contained within the CARTON (41163-917-76)
6	NDC:41163-917-82	2 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
6		100 CAPSULE, COATED ( TABLET) in 1 BOTTLE	This package is contained within the CARTON (41163-917-82)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/31/2011

Labeler - Supervalu Inc (006961411)

Registrant - L Perrigo Company (006013346)

Establishment
Name	Address	ID/FEI	Operations
Granules India Limited		918609236	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
L Perrigo Company		006013346	REPACK, RELABEL

Establishment
Name	Address	ID/FEI	Operations
Sixarp LLC, Praxis		016329513	REPACK

Revised: 01/2011 Supervalu Inc