EQUALINE PAIN RELIEF- acetaminophen tablet, 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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SuperValu Inc. Pain Relief Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. 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.
if you have ever had an allergic reaction to this product or any of its ingredients

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 take more than directed (see Liver warning)

adults and children 12 years and over	take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor
children under 12 years	ask a doctor

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

carrageenan, corn starch*, croscarmellose sodium*, FD&C red #40 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide *contains one or more of these ingredients

Questions or comments?

1-877-932-7948

Principal Display Panel

compare to Tylenol® EZ Tabs active ingredient

extra strength

pain relief

easy tabs

actual size

acetaminophen tablets, 500 mg

pain reliever/fever reducer

easy to swallow - sweet coated tablets

see new warnings and directions

Pain Relief Carton Image 1

Pain Relief Carton Image 2

EQUALINE PAIN RELIEF
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:41163-227
Route of Administration	ORAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
CARRAGEENAN
STARCH, CORN
CROSCARMELLOSE SODIUM
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
POVIDONE
STEARIC ACID
SUCRALOSE
TALC
TITANIUM DIOXIDE

Product Characteristics
Color	RED	Score	no score
Shape	ROUND (convex)	Size	10mm
Flavor		Imprint Code	L227
Contains

#	Item Code	Package Description
Packaging
1	NDC:41163-227-71	1 in 1 CARTON
1		50 in 1 BOTTLE
2	NDC:41163-227-78	1 in 1 CARTON
2		100 in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	02/24/2006

Labeler - Supervalu Inc (006961411)

Revised: 8/2012

Document Id: 52d86380-3b18-46bf-a993-c5ed7a08ad34

Set id: fa8fadba-7536-47db-a00d-03190d8f0826

Version: 2

Effective Time: 20120809

Supervalu Inc