Search by Drug Name or NDC

NDC 63187-0373-12 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 Proficient Rx LP. 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: 63187-0373-12
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen Rectal

Product Information

NDC	63187-0373
Product ID	63187-373_a4458cf8-9a74-4beb-858c-611588e6b6b0
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	Proficient Rx LP
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA070607
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0373-12 (63187037312)

Pricing Information	N/A
NDC Package Code	63187-373-12
Billing NDC	63187037312
Package	12 BLISTER PACK in 1 CARTON (63187-373-12) / 1 SUPPOSITORY in 1 BLISTER PACK
Marketing Start Date	2016-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 43fd900c-50c8-49c4-9f07-4fef924d533c 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.

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

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:63187-373(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:63187-373-12	12 in 1 CARTON	09/01/2016
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	12/14/2010

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-373) , RELABEL(63187-373)

Revised: 9/2022

Document Id: a4458cf8-9a74-4beb-858c-611588e6b6b0

Set id: 43fd900c-50c8-49c4-9f07-4fef924d533c

Version: 5

Effective Time: 20220901