Your browser does not support JavaScript! PAIN AND FEVER (ACETAMINOPHEN) TABLET [CARDINAL HEALTH]
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RxNorm Names

PAIN AND FEVER (acetaminophen) tablet
[Cardinal Health]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL unapproved drug other
NOTE:THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA. For further information about unapproved drugs, click here.
Drug Label Sections

Active Ingredients (in each tablet)

Acetaminophen USP, 325 mg

Purposes

Pain reliever/fever reducer
Relieves Pain & Fever without Aspirin

Regular Strength Tablets

See New Warnings Information

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

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, 9 am - 5 pm ET, Monday-Friday

COMPARE TO ACTIVE INGREDIENT IN REGULAR STRENGTH TYLENOLR*

*Rugby Laboratories, Inc. is not affiliated with the owner of the trademark TylenolR. Rugby Pain & Fever is distributed by Rugby Laboratories, Inc.

www.rugbylaboratories.com

Rubgy

Duluth, Georgia 30097

R0610

IT48470180313

Cardinal Health

Zanesville, OH 43701

Principal Display Panel

PAIN & FEVER

Acetaminophen USP, 325 mg tablets

REGULAR STRENGTH

QTY 30

Blister Label

Principal Display Panel

PAIN & FEVER

Acetaminophen USP

325 mg tablets

card label
PAIN AND FEVER 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55154-6814(NDC:0536-3222)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
POVIDONES 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (round flat faced beveled edge) Size10mm
FlavorImprint Code GPIA325
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-6814-930 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other02/23/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-6814)

Revised: 4/2014
 
Cardinal Health

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