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NDC 45802-0732-30 acetaminophen 120 mg/1 Details

acetaminophen 120 mg/1

acetaminophen is a RECTAL SUPPOSITORY in the HUMAN OTC DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is ACETAMINOPHEN.

MedlinePlus Drug Summary

Acetaminophen rectal is used to relieve mild to moderate pain from headaches or muscle aches and to reduce a fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 45802-0732-30
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen Rectal

Product Information

NDC	45802-0732
Product ID	45802-732_8700eaea-4a54-42f0-81f3-88036f77f6a5
Associated GPIs	64200010005205
GCN Sequence Number	004475
GCN Sequence Number Description	acetaminophen SUPP.RECT 120 MG RECTAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16903
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	acetaminophen
Proprietary Name Suffix	for children
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	SUPPOSITORY
Route	RECTAL
Active Ingredient Strength	120
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	Padagis Israel Pharmaceuticals Ltd
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA070607
Listing Certified Through	2024-12-31

Package

Package Images

NDC 45802-0732-30 (45802073230)

Pricing Information
NDC Package Code	45802-732-30
Billing NDC	45802073230
Package	12 BLISTER PACK in 1 CARTON (45802-732-30) / 1 SUPPOSITORY in 1 BLISTER PACK
Marketing Start Date	2011-03-09
NDC Exclude Flag	N
Price Per Unit	0.28842
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	ACETAMINOPHEN 120 MG SUPPOS
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 62b3d354-d7f5-4ba0-b233-ea6be0d7ff03 Details

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

Principal Display Panel

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

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN FOR CHILDREN

acetaminophen suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45802-732
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
Packaging
1	NDC:45802-732-33	100 in 1 CARTON	12/14/2010
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:45802-732-30	12 in 1 CARTON	03/09/2011
2		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	12/14/2010

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