Indications and uses
temporarily relieves minor aches and pains due to: headache muscle pain toothache menstrual pain colds minor pain of arthritis temporarily reduces fever
MICRO-COATED ASPIRIN 325 mg
- Manufacturer
- MAJOR PHARMACEUTICALS | Pharbest Pharmaceuticals, Inc.
- Effective date
- 2018-12-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:35:51
Label at a glance#
ProductMICRO-COATED ASPIRIN 325 mg
Active ingredientASPIRIN
Label structure9 sections
Dosage and administration
drink a full glass of water with each dose adults and children 12 years and over take 1 to 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours children under 12 years consult a doctor
Storage and handling
store at room temperature. Excursions permitted between 15 0 -30 0 C. Avoid excessive heat above 40 o C Tamper Evident: do not use if safety seal under cap is broken or missing
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Aspirin 325mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/ fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscle pain
- toothache
- menstrual pain
- colds
- minor pain of arthritis
- temporarily reduces fever
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
- asthma (wheezing)
- shock
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
- if you ever had an allergic reaction to this product or any of its ingredients
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
- an allergic reaction occurs. Seek medical help right away
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- 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
- ringing in the ears or loss of hearing occurs
- any new symptoms occur
These could be signs of a serious condition
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 1 to 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours |
| children under 12 years | consult a doctor |
Other information
- store at room temperature. Excursions permitted between 150-300C. Avoid excessive heat above 40oC
- Tamper Evident: do not use if safety seal under cap is broken or missing
Inactive ingredients
corn starch, hypromellose, microcrystalline cellulose, stearic acid, talc, triacetin
Questions or comments?
(800) 616-2471
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
COMPARE TO GENUINE BAYER®ASPIRIN ACTIVE INGREDIENT**
NDC 0904-6811-80
MICRO-COATED
ASPIRIN
325 mg
PAIN RELIEVER
FEVER REDUCER
(NSAID)
FAST, SAFE PAIN RELIEF
1000 Coated Tablets
MAJOR®
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6811-80 | EA - Each | 0904-6811 | eb7466d0-affb-4f1a-8546-4ce17ec807d1 | 1 | 2019-02-13 |
Products#
Every source-derived product name is available through these pages.
- MICRO-COATED ASPIRIN 325 mg
- Aspirin
- STARCH, CORN
- HYPROMELLOSE, UNSPECIFIED
- CELLULOSE, MICROCRYSTALLINE
- STEARIC ACID
- TALC
- TRIACETIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0904-6811 | 0904-6811-80 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASPIRIN | R16CO5Y76E | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TRIACETIN | XHX3C3X673 | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| debe6da6-f7f8-4b32-8436-0193a3949d63 | ccef06e2-a6eb-4281-904e-aeb2aa106498 | 2022-12-21 | Warnings | ccef06e2-a6eb-4281-904e-aeb2aa106498 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.