Topco Associates LLC. Fever Reducer Drug Facts

Active ingredient (in each rectal suppository)

Acetaminophen 120 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 5 doses in 24 hours, which is the maximum daily amount
•: 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

•: your child has liver disease
•: your 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 5 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 (1-800-222-1222). 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 3 years	Do not use unless directed by a doctor
3 to 6 years	Use a suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)

Other information

•: store at 20-25°C (68-77°F) or in a cool place
•: tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged.

Inactive ingredient

hydrogenated vegetable oil

Questions or comments?

1-888-423-0139

Principal Display Panel

AGES 3 – 6 YEARS

For Children

Fever Reducer

ACETAMINOPHEN SUPPOSITORIES 120 mg

Pain reliever / Fever reducer

SEE NEW WARNING

COMPARE TO FEVERALL® active ingredient

12 RECTAL SUPPOSITORIES

120 mg EACH

TOPCARE FEVER REDUCER
acetaminophen suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-579
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	120 mg

Ingredient Name	Strength
Inactive Ingredients
COTTONSEED OIL (UNII: H3E878020N)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-579-53	12 in 1 CARTON	09/26/2011	10/13/2017
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA070607	09/26/2011	10/13/2017

Labeler - Topco Associates LLC (006935977)

Revised: 10/2016

Document Id: c1cea2eb-fea9-4d11-8afa-3151d30bbc1c

Set id: 72a33640-ca7f-460d-9357-772d5bf56bac

Version: 3

Effective Time: 20161027

Topco Associates LLC