ACETAMINOPHEN PAIN RELIEVER FEVER REDUCER- acetaminophen suppository 
Padagis Israel Pharmaceuticals Ltd

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Perrigo Acetaminophen Suppositories USP, 650 mg Drug Facts

Active ingredient (in each rectal suppository)

Acetaminophen 650 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

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

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

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 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.

If pregnant or breast-feeding,

ask a health professional before use.

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

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 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 Adults

Acetaminophen Suppositories USP, 650 mg

Pain Reliever/Fever Reducer

Ages 12 years and older

See New Warning

50 RECTAL SUPPOSITORIES, 650 mg EACH

Acetaminophen Suppositories Image 1
Acetaminophen Suppositories Image 2
ACETAMINOPHEN  PAIN RELIEVER FEVER REDUCER
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-730
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
COTTONSEED OIL (UNII: H3E878020N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45802-730-3250 in 1 CARTON11/22/2010
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:45802-730-3012 in 1 CARTON10/28/2010
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:45802-730-33100 in 1 CARTON10/28/2010
31 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:45802-730-001 in 1 BLISTER PACK; Type 0: Not a Combination Product10/28/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07060810/28/2010
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 11/2021
Document Id: 4ee4558c-bd55-4abf-9210-db4a178dade3
Set id: b43974c3-4db9-4201-beee-b22596a2b241
Version: 5
Effective Time: 20211109
 
Padagis Israel Pharmaceuticals Ltd