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NDC 45802-0730-30 acetaminophen 650 mg/1 Details

acetaminophen 650 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: 45802-0730-30
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen Rectal

Product Information

NDC	45802-0730
Product ID	45802-730_4ee4558c-bd55-4abf-9210-db4a178dade3
Associated GPIs	64200010005220
GCN Sequence Number	004478
GCN Sequence Number Description	acetaminophen SUPP.RECT 650 MG RECTAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16907
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	acetaminophen
Proprietary Name Suffix	pain reliever fever reducer
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	SUPPOSITORY
Route	RECTAL
Active Ingredient Strength	650
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	ANDA070608
Listing Certified Through	2024-12-31

Package

Package Images

NDC 45802-0730-30 (45802073030)

Pricing Information
NDC Package Code	45802-730-30
Billing NDC	45802073030
Package	12 BLISTER PACK in 1 CARTON (45802-730-30) / 1 SUPPOSITORY in 1 BLISTER PACK
Marketing Start Date	2010-10-28
NDC Exclude Flag	N
Price Per Unit	0.34072
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	ACETAMINOPHEN 650 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 b43974c3-4db9-4201-beee-b22596a2b241 Details

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

Principal Display Panel

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

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN PAIN RELIEVER FEVER REDUCER

acetaminophen suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45802-730
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:45802-730-32	50 in 1 CARTON	11/22/2010
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:45802-730-30	12 in 1 CARTON	10/28/2010
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:45802-730-33	100 in 1 CARTON	10/28/2010
3		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:45802-730-00	1 in 1 BLISTER PACK; Type 0: Not a Combination Product	10/28/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA070608	10/28/2010

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