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NDC 59779-0579-53 fever reducing 120 mg/1 Details

fever reducing 120 mg/1

fever reducing is a RECTAL SUPPOSITORY in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. 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: 59779-0579-53
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen Rectal

Product Information

NDC	59779-0579
Product ID	59779-579_227f1efc-59b8-45af-b07e-bf778d7f9dfd
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	fever reducing
Proprietary Name Suffix	childrens
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	CVS Pharmacy
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA070607
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59779-0579-53 (59779057953)

Pricing Information	N/A
NDC Package Code	59779-579-53
Billing NDC	59779057953
Package	12 BLISTER PACK in 1 CARTON (59779-579-53) / 1 SUPPOSITORY in 1 BLISTER PACK
Marketing Start Date	2010-01-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9d89544f-3a66-4f23-b609-381d027e0c95 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 ingredients

hydrogenated vegetable oil

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in FeverAll®

For Children

Fever Reducing Suppositories

ACETAMINOPHEN SUPPOSITORIES 120 mg

Pain reliever; Fever reducer

Ages 3-6 years

Actual Size

12 RECTAL SUPPOSITORIES, 120 mg EACH

INGREDIENTS AND APPEARANCE

FEVER REDUCING CHILDRENS

acetaminophen suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-579
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
Packaging
1	NDC:59779-579-53	12 in 1 CARTON	01/21/2010
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	01/21/2010

Labeler - CVS Pharmacy (062312574)

Revised: 11/2019

Document Id: 227f1efc-59b8-45af-b07e-bf778d7f9dfd

Set id: 9d89544f-3a66-4f23-b609-381d027e0c95

Version: 4

Effective Time: 20191120