PAIN AND FEVER- acetaminophen tablet
Cardinal Health

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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Drug Facts

Active Ingredients (in each tablet)

Acetaminophen USP, 325 mg

Purposes

Pain reliever/fever reducer
Relieves Pain & Fever without Aspirin

Regular Strength Tablets

Uses

temporarily reduces fever and relives minor aches and pains caused by

•: Headache
•: muscular aches
•: common cold
•: toothache
•: premenstrual and menstrual cramps

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

•: adult takes more than 12 tablets in 24 hours,which is the maximum daily amount
•: child takes more than 5 tablets in 24 hours, which is the maximum daily amount
•: taken with other drugs containing acetaminophen
•: adult has 3 or more alcoholic drinks every day while using this product

Do not use

with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if the user has

liver disease

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin

Stop use and ask a doctor if

•: adult's pain gets worse or lasts more than 10 days
•: child's pain gets worse or lasts more than 5 days
•: fever gets worse or lasts more than 3 days
•: redness or swelling is present
•: any new symptoms appear
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. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Directions

Adults and children 12 years and over	1-2 tablets every 4 hours or 2-3 tablets every 6 hours while symptoms last, not more than 12 tablets in 24 hours.
Children 6 to 11 years	1 tablet every 4 hours while symptoms last, not more than 5 tablets in 24 hours.
Children under 6 years	do not use

Other information

store at room temperature

Inactive Ingredients

pregelatinized corn starch, povidone, sodium starch glycolate, stearic acid

Questions or comments?

call 1-800-645-2158

COMPARE TO ACTIVE INGREDIENT IN REGULAR STRENGTH TYLENOLR*

*Rugby Laboratories, Inc. is not affiliated with the owner of the trademark TylenolR.

www.rugbylaboratories.com

Distributed By: Rubgy Laboratories

31778 Enterprise Drive, Livonia, MI 48150

Rev. 04/13

IT48470180215

Cardinal Health

Zanesville, OH 43701

Principal Display Panel

PAIN & FEVER

Acetaminophen USP

325 mg tablets

Principal Display Panel

PAIN & FEVER

Acetaminophen USP, 325 mg tablets

REGULAR STRENGTH

QTY 30

Principal Display Panel

Pain & Fever

Acetaminophen USP

325 mg tablets

Principal Display Panel

Pain & Fever

Acetaminophen USP, 325 mg tablets

Regular Strength

QTY 28

PAIN AND FEVER
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55154-6814(NDC:0536-3222)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (round flat faced beveled edge)	Size	10mm
Flavor		Imprint Code	GPIA325
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55154-6814-9	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	02/23/2011	12/15/2015
2	NDC:55154-6814-3	28 in 1 BLISTER PACK; Type 0: Not a Combination Product	02/23/2011	08/15/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	02/23/2011	12/15/2015

Labeler - Cardinal Health (188557102)

Name	Address	ID/FEI	Business Operations
Establishment
Cardinal Health		188557102	REPACK(55154-6814)

Revised: 5/2017

Document Id: eeba8cfe-fd6d-434d-8bab-c681570fe16e

Set id: 583b5f8d-780c-429e-9384-d2adcee828c6

Version: 8

Effective Time: 20170508

Cardinal Health