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NDC 71335-0608-02 Aspirin 81 mg/1 Details

Aspirin 81 mg/1

Aspirin is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is ASPIRIN.

MedlinePlus Drug Summary

Prescription aspirin is used to relieve the symptoms of rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), osteoarthritis (arthritis caused by breakdown of the lining of the joints), systemic lupus erythematosus (condition in which the immune system attacks the joints and organs and causes pain and swelling) and certain other rheumatologic conditions (conditions in which the immune system attacks parts of the body). Nonprescription aspirin is used to reduce fever and to relieve mild to moderate pain from headaches, menstrual periods, arthritis, toothaches, and muscle aches. Nonprescription aspirin is also used to prevent heart attacks in people who have had a heart attack in the past or who have angina (chest pain that occurs when the heart does not get enough oxygen). Nonprescription aspirin is also used to reduce the risk of death in people who are experiencing or who have recently experienced a heart attack. Nonprescription aspirin is also used to prevent ischemic strokes (strokes that occur when a blood clot blocks the flow of blood to the brain) or mini-strokes (strokes that occur when the flow of blood to the brain is blocked for a short time) in people who have had this type of stroke or mini-stroke in the past. Aspirin will not prevent hemorrhagic strokes (strokes caused by bleeding in the brain). 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. Aspirin is also available in combination with other medications such as antacids, pain relievers, and cough and cold medications. This monograph only includes information about the use of aspirin alone. If you are taking a combination product, read the information on the package or prescription label or ask your doctor or pharmacist for more information.

Related Packages: 71335-0608-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Aspirin

Product Information

NDC	71335-0608
Product ID	71335-0608_c3181543-331a-461c-8b7a-c10b9d39524a
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Aspirin
Proprietary Name Suffix	Low Dose Safety Coated
Non-Proprietary Name	Aspirin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, COATED
Route	ORAL
Active Ingredient Strength	81
Active Ingredient Units	mg/1
Substance Name	ASPIRIN
Labeler Name	Bryant Ranch Prepack
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	n/a

Package

Package Images

NDC 71335-0608-02 (71335060802)

Pricing Information	N/A
NDC Package Code	71335-0608-2
Billing NDC	71335060802
Package	30 TABLET, COATED in 1 BOTTLE (71335-0608-2)
Marketing Start Date	2017-12-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c3181543-331a-461c-8b7a-c10b9d39524a Details

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
ask your doctor about other uses for safety coated 81 mg aspirin

Warnings

Reye's syndrome: Children and teenagers who have or are recovering 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 an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

hives
facial swelling
shock
asthma (wheezing)

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 steroid drug
take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Do not use

if you are allergic to aspirin or any other pain reliever/fever reducer.

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 have asthma
you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

gout
diabetes
arthritis

Stop use and ask a doctor if

you experience 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
an allergic reaction occurs. Seek medical help right away.
new symptoms occur
pain gets worse or lasts more than 10 days
redness or swelling is present
ringing in the ears or loss of hearing occurs

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 because it may cause problems in the unborn child or complications during delivery.

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: do not use

Other information

store at controlled room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

anhydrous lactose**, black iron oxide**, brown iron oxide**, croscarmellose sodium**, D&C yellow #10, FD&C yellow #6**, hypromellose**, methacrylic acid copolymer, microcrystalline cellulose, mineral oil**, polysorbate 80**, potassium hydroxide**, pregelatinized starch**, propylene glycol**, purified water**, shellac**, silicon dioxide, simethicone**, sodium bicarbonate**, sodium hydroxide**, sodium lauryl sulfate**, stearic acid**, talc, titanium dioxide, triethyl citrate, yellow iron oxide**

**contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

HOW SUPPLIED

NDC: 71335-0608-8: 15 Tablets in a BOTTLE

NDC: 71335-0608-1: 120 Tablets in a BOTTLE

NDC: 71335-0608-2: 30 Tablets in a BOTTLE

NDC: 71335-0608-3: 100 Tablets in a BOTTLE

NDC: 71335-0608-4: 20 Tablets in a BOTTLE

NDC: 71335-0608-5: 90 Tablets in a BOTTLE

NDC: 71335-0608-6: 60 Tablets in a BOTTLE

NDC: 71335-0608-7: 36 Tablets in a BOTTLE

NDC: 71335-0608-9: 10 Tablets in a BOTTLE

PRINCIPAL DISPLAY PANEL

Aspirin 81 mg EC Tablet

INGREDIENTS AND APPEARANCE

ASPIRIN LOW DOSE SAFETY COATED

aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-0608(NDC:50804-227)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	E;T81;1
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-0608-1	120 in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2017
2	NDC:71335-0608-2	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2017
3	NDC:71335-0608-3	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2017
4	NDC:71335-0608-4	20 in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2017
5	NDC:71335-0608-5	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2017
6	NDC:71335-0608-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2017
7	NDC:71335-0608-7	36 in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2017
8	NDC:71335-0608-8	15 in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2017
9	NDC:71335-0608-9	10 in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	03/15/2013	01/05/2024

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-0608) , RELABEL(71335-0608)

Revised: 2/2022

Document Id: c3181543-331a-461c-8b7a-c10b9d39524a

Set id: c3181543-331a-461c-8b7a-c10b9d39524a

Version: 5

Effective Time: 20220209