PAIN RELIEF- acetaminophen tablet
HyVee 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.

----------

Hy-Vee, 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
•: 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 tablets 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 take more than directed (see Liver warning)

adults and children 12 years and over	• take 2 tablets every 6 hours as needed • do not take more than 8 tablets 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

croscarmellose sodium, povidone, pregelatinized starch, stearic acid

Questions or comments?

1-800-719-9260

Principal Display Panel

See New Warnings Information

Compare to Extra Strength Tylenol® active ingredient

Pain Relief

Extra Strength

Pain Reliever - Fever Reducer

Acetaminophen

(500 mg each)

Pain Relief Carton Image 1

Pain Relief Carton Image 2

PAIN RELIEF
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42507-405
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POVIDONES (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	500MG;L405
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42507-405-78	1 in 1 CARTON	01/15/1989	11/25/2015
1		100 in 1 BOTTLE; 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	01/15/1989	11/25/2015

Labeler - HyVee Inc (006925671)

Revised: 11/2017

Document Id: a7d9c7f4-48fe-4dc9-8b39-ba26d5ac8e6a

Set id: 702a3603-3f65-4a05-a9be-52454aa47442

Version: 2

Effective Time: 20171128

HyVee Inc