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

card label

Principal Display Panel

PAIN & FEVER

Acetaminophen USP, 325 mg tablets

REGULAR STRENGTH

QTY 30

lidding label

Principal Display Panel

Pain & Fever

Acetaminophen USP

325 mg tablets

card label

Principal Display Panel

Pain & Fever

Acetaminophen USP, 325 mg tablets

Regular Strength

QTY 28

lidding label
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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONES (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     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55154-6814-9 30 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:55154-6814-3 28 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 02/23/2011
Labeler - Cardinal Health (188557102)
Establishment
Name Address ID/FEI Business Operations
Cardinal Health 188557102 REPACK(55154-6814)

Revised: 4/2015
Document Id: fff99a41-3857-479c-a4df-fb06a6c6bf6b
Set id: 583b5f8d-780c-429e-9384-d2adcee828c6
Version: 7
Effective Time: 20150416
 
Cardinal Health