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NDC 49483-0330-10 Low Dose Miniprin 81 mg/1 Details

Low Dose Miniprin 81 mg/1

Low Dose Miniprin is a ORAL TABLET, DELAYED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Time-Cap Labs, Inc. 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: 49483-0330-10
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Aspirin

Product Information

NDC	49483-0330
Product ID	49483-330_7d5fb951-93ac-12fa-e053-2991aa0abbf3
Associated GPIs	64100010000601
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	Low Dose Miniprin
Proprietary Name Suffix	Enteric Safety Coated
Non-Proprietary Name	Aspirin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, DELAYED RELEASE
Route	ORAL
Active Ingredient Strength	81
Active Ingredient Units	mg/1
Substance Name	ASPIRIN
Labeler Name	Time-Cap Labs, Inc
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 FINAL
Application Number	part343
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49483-0330-10 (49483033010)

Pricing Information	N/A
NDC Package Code	49483-330-10
Billing NDC	49483033010
Package	1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-330-10)
Marketing Start Date	2018-12-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5a38a643-55b0-4a6c-84e1-ee2374435114 Details

SPL UNCLASSIFIED SECTION

active ingredient (in each tablet) Purpose Aspirin 81 mg (NSAID)................................Pain reliever nonsteroidal anti-inflammatory drug

SPL UNCLASSIFIED SECTION

Uses temporarily relieves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

SPL UNCLASSIFIED SECTION

anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, d&c yellow#10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, Polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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 pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear ringing in the ears or a loss of hearing occurs

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

PAIN RELIEVER

SPL UNCLASSIFIED SECTION

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

use by expiration date on package

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOW DOSE MINIPRIN ENTERIC SAFETY COATED

aspirin tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49483-330
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIMETHICONE (UNII: 92RU3N3Y1O)
TALC (UNII: 7SEV7J4R1U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	embossed;upper;8;lower;plain
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49483-330-12	120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/19/2018
2	NDC:49483-330-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/19/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part343	08/11/2010

Labeler - Time-Cap Labs, Inc (037052099)

Name	Address	ID/FEI	Business Operations
Establishment
Time-Cap Labs, Inc		037052099	manufacture(49483-330)

Revised: 12/2018

Document Id: 7d5fb951-93ac-12fa-e053-2991aa0abbf3

Set id: 5a38a643-55b0-4a6c-84e1-ee2374435114

Version: 2

Effective Time: 20181219

Search by Drug Name or NDC

NDC 49483-0330-10 Low Dose Miniprin 81 mg/1 Details

Low Dose Miniprin 81 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 49483-0330-10 (49483033010)

Contents

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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