FEVERALL - acetaminophen suppository 
Cardinal Health

Disclaimer: 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.

----------

See New Warnings

See New Warnings Information

Active ingredient

In each rectal suppository: Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Keep Out of Reach of Children

Keep out of reach of children.

Uses

Temporarily reduces fever, relieves minor aches, pains and headache

Warnings

This package is intended for institutional use only. If pregnant or breast-feeding, ask a health professional before use. If swallowed or in case of overdose, get medical help or contact a poison Control Center right away. Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.

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

For rectal use only

Drug Facts (Continued)

Do not use

Ask a doctor before use if

Stop use and ask a doctor if

Directions

Do not use more than directed, remove wrapper, carefully insert suppository well up into the rectum.

adults and children 12 years and older: 1 suppository every 4 to 6 hours while symptoms last. Do not exceed 6 suppositories in any 24-hour period. Children under 12 years: ask a doctor.

Inactive ingredients

Glycerol monostearate, hydrogenated vegetable oil, polyoxyethylene stearate, polysorbate 80

Storage

Store at 2-27 C (35-80 F)

Tamper-evident: Suppositories are individually wrapped. Do not use if imprinted wrapper is opened or damaged.

Dist. by Actavis Mid Atlantic LLC

Lincolnton, NC 28092 USA

Questions? 1-800-432-8534 (select option #2) between 9 am and 4 pm EST. Monday-Friday.

Repackaged by Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Feverall® 650 MG Each

Acetaminophen Suppositories

Adults' Ages 12 Years and Older

10 Rectal Suppositories

bag label

FEVERALL 
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-6050(NDC:0472-1203)
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE 
HYDROGENATED CASTOR OIL 
POLYOXYL 40 STEARATE 
POLYSORBATE 80 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:55154-6050-010 BLISTER PACK ( BLISTER PACK) in 1 BAGcontains a BLISTER PACK
11 SUPPOSITORY ( SUPPOSITORY) in 1 BLISTER PACKThis package is contained within the BAG (55154-6050-0)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/06/2011

Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK

Revised: 06/2011 Cardinal Health