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Feverall

Cardinal Health

Feverall 650 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

Feverall 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

  • an adult or child 12 years and older takes more than 6 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • an adult takes 3 or more alcoholic drinks everyday while using this product.

For rectal use only

Drug Facts (Continued)

Do not use

  • in children under 12 years.
  • if you are allergic to acetaminophen
  • 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.
  • you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • fever lasts for more than 3 days (72 hours), or recurs.
  • pain gets worse or lasts more than 10 days
  • new symptoms occur.
  • redness or swelling is present in the painful area. These may be signs of a serious condition.

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

Feverall

Feverall

Acetaminophen SUPPOSITORY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55154-6050(NDC:0472-1203)
Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 650 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERYL MONOSTEARATE
polysorbate 80
PEG-100 STEARATE
Hydrogenated Palm Kernel Oil

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:55154-6050-0 10 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA018337 2011-06-06


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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