ASPIRIN 81 MG- aspirin tablet, coated

Aspirin 81 mg by

Drug Labeling and Warnings

Aspirin 81 mg by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflamatory drug

Purpose

Pain reliever

Uses

temporarily relieves minor aches and pains

Because of its delayed action, this product will not prodice fast relief of headaches or other symptoms needing immediate relief.

ask your doctor about other uses for enteric-coated 81 mg Aspirin

Warnings

Reye's syndrome: Children and teenagers who have or are recoving from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be early sign of Reye's syndrome, a rare but serious illness.

OTHER SAFETY INFORMATION

Allergy Alert: Aspirin may cause a severe allergic reaction which may include:

- hives

- facial swelling

- shock

- asthma (wheezing)

SPL UNCLASSIFIED SECTION

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

- are age 60 or older

- have had stomach ulcers or bleeding problems

- take a blood thinning (anticoagulant) or steriod drug

- take other drugs contiaining prescription or nonprescription NSAIDs (aspirin, ibuprofen, naprozen, or others)

- have 3 or more alcoholic drinks every day while using this product

- take more or for longer time than directed

DO NOT USE

Do not use: if you are allergic to aspirin or any other pain reliver/fever reducer

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

- taking a prescription drug for diabetes, gout, or arthritis

- taking any other drug

- under a doctor's care for any serious condition

STOP USE

Stop use and ask a doctor if

- an allergic reaction occurs. Seek medical help right away.

- you are experierance any of the following signs of stomach bleeding: feel faint, have bloody or black stools, vomit blood, have stomach pain that does not get better

- pain gets worse or lasts more than 10 days

- redness or swelling is present

- new symptoms occur

- ringing in the ears or a loss of hearing occurs.

these could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor becwause it may cause problems in the unborn child or complications during delivery.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

- Drink a full glass of water with each dose

- adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor

- children under 12 years: consult a doctor

Other information

- store at 25°C (77°F) excursions premitted between 15°-30°C (59°-86°F)

- Use by expiration date on package

Inactive ingredients

corn starch, pregelatinized starch, povidone. microcrystalline cellulose, colloidal silicon dioxide, stearic acid, methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate, d&c yellow #10

ASK DOCTOR

Ask a doctor before use if

stomach bleeding warning applies to you

you have a history of stomach problems, such as heartburn

you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

you are taking a diuretic

you have asthma

you have not been drinking fluids

you have lost a lot of fluid due to vomiting or diarrhea

Drug Facts

HOW SUPPLIED

NDC: 71335-1774-8: 15 Tablets in a BOTTLE, PLASTIC

NDC: 71335-1774-1: 120 Tablets in a BOTTLE, PLASTIC

NDC: 71335-1774-2: 30 Tablets in a BOTTLE, PLASTIC

NDC: 71335-1774-3: 100 Tablets in a BOTTLE, PLASTIC

NDC: 71335-1774-4: 20 Tablets in a BOTTLE, PLASTIC

NDC: 71335-1774-5: 90 Tablets in a BOTTLE, PLASTIC

NDC: 71335-1774-6: 60 Tablets in a BOTTLE, PLASTIC

NDC: 71335-1774-7: 36 Tablets in a BOTTLE, PLASTIC

PRINCIPAL DISPLAY PANEL

Aspirin 81 mg EC Tablet

INGREDIENTS AND APPEARANCE

ASPIRIN 81 MG 
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71335-1774(NDC:69618-066)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code	17;S
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71335-1774-8	15 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2021
2	NDC: 71335-1774-1	120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2021
3	NDC: 71335-1774-2	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2021
4	NDC: 71335-1774-3	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2021
5	NDC: 71335-1774-4	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2021
6	NDC: 71335-1774-5	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2021
7	NDC: 71335-1774-6	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2021
8	NDC: 71335-1774-7	36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	10/01/2020

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(71335-1774) , RELABEL(71335-1774)