Aspirin Suppositories, Usp

Aspirin Suppositories, Usp
SPL v6
SPL
SPL Set ID cce244aa-cd79-49c8-b68e-267f2bd0ef67
Route
RECTAL
Published
Effective Date 2022-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (300 mg)
Inactive Ingredients
Hydrogenated Palm Kernel Oil Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
UNAPPROVED DRUG OTHER Active Since 1990-09-01

Description

Aspirin Suppositories, USP 300 mg (5 grains) Each suppository contains 300 mg (5 grains) of aspirin.


Medication Information

Description

Aspirin Suppositories, USP 300 mg (5 grains) Each suppository contains 300 mg (5 grains) of aspirin.

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.

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.

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.

Indications:

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

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 Padagis

Minneapolis, MN 55427

Rev 04-22

Active Ingredient

Aspirin Suppositories, USP 300 mg (5 grains)

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

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

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.


Structured Label Content

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.

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.

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.

Indications:

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

Alcohol Warning: (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 Padagis

Minneapolis, MN 55427

Rev 04-22

Active Ingredient (Active ingredient)

Aspirin Suppositories, USP 300 mg (5 grains)

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

Package/label Principal Display Panel – 300 Mg (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

Keep This and All Drugs Out of the Reach of Children. (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.


Advanced Ingredient Data


Raw Label Data

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