FEVERALL INFANTS- acetaminophen suppository

Feverall by

Drug Labeling and Warnings

Feverall by is a Otc medication manufactured, distributed, or labeled by Taro Pharmaceuticals U.S.A. Inc., G&W NC Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each rectal suppository)

Acetaminophen, USP 80 mg

Purposes

Pain reliever/fever reducer

Uses

temporarily

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

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if your child takes

• more than 4 doses in 24 hours, which is the maximum daily amount for ages 6 to 11 months
• more than 5 doses in 24 hours, which is the maximum daily amount for ages 12 to 36 months
• with other drugs containing acetaminophen

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

• skin reddening
• blisters
• rash

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

For rectal use only.

Do not use

• 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

• the child has liver disease.
• the child is taking the blood thinning drug warfarin.

Stop use and ask a doctor if

• fever lasts more than 3 days (72 hours), or recurs.
• pain lasts more than 3 days or gets worse.
• new symptoms occur.
• redness or swelling is present in the painful area.

These may be signs of a serious condition.

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

• this product does not contain directions or warnings for adult use
• do not use more than directed
• remove wrapper
• carefully insert suppository well up into the rectum

Dosing Chart

Age	Dose
under 6 months	Do not use unless directed by a doctor
6 to 11 months	Use 1 suppository every 6 hours; (maximum of 4 doses in 24 hours)
12 to 36 months	Use 1 suppository every 4 to 6 hours; (maximum of 5 doses in 24 hours)

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

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

PRINCIPAL DISPLAY PANEL - 6 Suppository Blister Pack Carton

NDC: 51672-2114-2

RECTAL
SUPPOSITORY*

*actual size

Doctor Recommended

Pain Reliever/Fever Reducer

• ✓ No Parabens or Any Other Preservatives
• ✓ No Artificial Colors

INFANTS'
ages 6-36 months

FeverAll®

ACETAMINOPHEN SUPPOSITORIES

Pain Reliever/Fever Reducer

6
Rectal
Suppositories

80
mg
each

INGREDIENTS AND APPEARANCE

FEVERALL   INFANTS
acetaminophen suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51672-2114
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	80 mg

Inactive Ingredients
Ingredient Name	Strength
glyceryl monostearate (UNII: 230OU9XXE4)
hydrogenated palm kernel oil (UNII: FM8D1RE2VP)
PEG-100 stearate (UNII: YD01N1999R)
polysorbate 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51672-2114-2	6 in 1 CARTON	12/12/2013
1	NDC: 51672-2114-0	1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 51672-2114-4	50 in 1 CARTON	12/12/2013
2	NDC: 51672-2114-0	1 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
NDA	NDA018337	12/12/2013

Labeler - Taro Pharmaceuticals U.S.A. Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
G&W NC Laboratories, Inc.		079419931	MANUFACTURE(51672-2114)