FDA Label for Feverall Adults

Other

Drug Facts

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

Active Ingredient (In Each Rectal Suppository)

Acetaminophen, USP 650 mg

Purposes

Pain reliever/fever reducer

Uses

temporarily

• reduces fever
• relieves minor aches, pains, and headache

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 every day while using this product

Otc - Stop Use

If a skin reaction occurs, stop use and seek medical help right away.

For rectal use only.

Stop use and ask a doctor if

• fever lasts 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.

Otc - Do Not Use

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.

Otc - Ask Doctor

Ask a doctor before use if

• you have liver disease.
• you are taking the blood thinning drug warfarin.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. 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.

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
  
  

Other Information

• store at 2°-27°C (35°-80°F)
• do not use if imprinted suppository wrapper is opened or damaged

Inactive Ingredients

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

Questions?

call 1-866-923-4914

Principal Display Panel - 50 Suppository Carton

ADULTS'
ages 12 years & older

FeverAll_®
ACETAMINOPHEN SUPPOSITORIES

Pain Reliever/Fever Reducer

NOT FOR RETAIL SALE
NDC 51672-2117-4

RECTAL
SUPPOSITORY*

*actual size

Doctor Recommended

50
Rectal
Suppositories

650
mg
each

Principal Display Panel - 50 Suppository Carton - feverall adult 01