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NDC 00574-7034-12 aspirin 300 mg/1 Details

aspirin 300 mg/1

aspirin is a RECTAL SUPPOSITORY in the HUMAN OTC DRUG category. It is labeled and distributed by Padagis US LLC. The primary component is ASPIRIN.

MedlinePlus Drug Summary

Aspirin rectal is used to reduce fever and to relieve mild to moderate pain from headaches, menstrual periods, arthritis, toothaches, and muscle aches. Aspirin is in a group of medications called salicylates. It works by stopping the production of certain natural substances that cause fever, pain, swelling, and blood clots.

Related Packages: 00574-7034-12
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Aspirin Rectal

Product Information

NDC	00574-7034
Product ID	0574-7034_1fde5a34-6494-43b5-a12a-c3ef3964d882
Associated GPIs	64100010005218
GCN Sequence Number	004371
GCN Sequence Number Description	aspirin SUPP.RECT 300 MG RECTAL
HIC3	H3D
HIC3 Description	ANALGESIC/ANTIPYRETICS, SALICYLATES
GCN	16696
HICL Sequence Number	001820
HICL Sequence Number Description	ASPIRIN
Brand/Generic	Generic
Proprietary Name	aspirin
Proprietary Name Suffix	n/a
Non-Proprietary Name	aspirin
Product Type	HUMAN OTC DRUG
Dosage Form	SUPPOSITORY
Route	RECTAL
Active Ingredient Strength	300
Active Ingredient Units	mg/1
Substance Name	ASPIRIN
Labeler Name	Padagis US LLC
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00574-7034-12 (00574703412)

Pricing Information	N/A
NDC Package Code	0574-7034-12
Billing NDC	00574703412
Package	12 PACKET in 1 CARTON (0574-7034-12) / 1 SUPPOSITORY in 1 PACKET
Marketing Start Date	1990-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cce244aa-cd79-49c8-b68e-267f2bd0ef67 Details

Active ingredient

Aspirin Suppositories, USP 300 mg (5 grains)

Each suppository contains 300 mg (5 grains) of aspirin.

Aspirin Suppositories, USP 600 mg (10 grains)

Each suppository contains 600 mg (10 grains) of aspirin.

Indications:

For the relief of minor aches, pains and headache and for reduction of fever.

Directions

Remove suppository from plastic packet and insert into the rectum as far as possible. Adult: One suppository every 4 hours for no more than 10 days or as directed by a physician. Children under 12 years of age: Consult a physician.

Caution:

Suppositories sealed in imprinted plastic packet. Do not use if imprinted packet is opened or damaged.

Store in a cool place 8° - 15°C (46° - 59°F) or refrigerate.

Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

Warnings

CHILDREN AND TEENAGERS WHO HAVE OR ARE RECOVERING FROM CHICKEN POX, FLU SYMPTOMS, OR FLU SHOULD NOT USE THIS PRODUCT. IF NAUSEA, VOMITING, OR FEVER OCCUR, CONSULT A DOCTOR BECAUSE THESE SYMPTOMS COULD BE AN EARLY SIGN OF REYE SYNDROME, A RARE BUT SERIOUS ILLNESS.

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING DELIVERY.

ALCOHOL WARNING:

If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

Manufactured by Perrigo®

Minneapolis, MN 55427

Rev 05-19 B

Package/Label Principal Display Panel – 300 mg

NDC 0574-7034-12

Aspirin Suppositories, USP

300 mg (5 grains)

For relief of pain and reduction of fever

UNIT DOSE

12 Suppositories

Package/Label Principal Display Panel – 600 mg

NDC 0574-7036-12

Aspirin Suppositories, USP

600 mg (10 grains)

For relief of pain and reduction of fever

UNIT DOSE

12 Suppositories

INGREDIENTS AND APPEARANCE

ASPIRIN

aspirin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0574-7034
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	300 mg

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0574-7034-12	12 in 1 CARTON	09/01/1990
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	09/01/1990