ACETAMINOPHEN FOR CHILDREN- acetaminophen suppository 
Padagis Israel Pharmaceuticals Ltd

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Perrigo Acetaminophen Suppositories USP, 120 mg 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 1 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?

1-800-719-9260

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Compare to FeverAll® active ingredient

For Children

Acetaminophen Suppositories USP, 120 mg

Pain Reliever/Fever Reducer

Ages 3-6 years

See New Warning

12 RECTAL SUPPOSITORIES, 120 mg EACH

Acetaminophen Suppositories Image 1
Acetaminophen Suppositories Image 2
ACETAMINOPHEN  FOR CHILDREN
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-732
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN120 mg
Inactive Ingredients
Ingredient NameStrength
COTTONSEED OIL (UNII: H3E878020N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45802-732-33100 in 1 CARTON12/14/2010
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:45802-732-3012 in 1 CARTON03/09/2011
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07060712/14/2010
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 11/2021
Document Id: 8700eaea-4a54-42f0-81f3-88036f77f6a5
Set id: 62b3d354-d7f5-4ba0-b233-ea6be0d7ff03
Version: 5
Effective Time: 20211110
 
Padagis Israel Pharmaceuticals Ltd