Active Ingredients And Purpose
OTC - PURPOSE SECTION
Pain Reliever/fever reducer
OTC - ACTIVE INGREDIENT SECTION
In each Tablet Asprin 500 mg (NSAID*) *non-steroidal anti-inflammatory drug
382R ASA 500 MG
- Set ID
- efc7d42a-241a-422d-bc08-be2f5f774b62
- Manufacturer
- Time-Cap Labs, Inc
- Effective date
- 2018-12-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:57:44
Key Label Information
Uses
INDICATIONS & USAGE SECTION
Use for the temporary relief of minor aches and pains due to: headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor
Warnings
OTC - DO NOT USE SECTION
Do not use if you are allergic to aspirin or any other pain reliever/fever reducer
OTC - PREGNANCY OR BREAST FEEDING 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.
WARNINGS 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, asthmaaa9wheezing) 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.
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
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 while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor
Other Label Information
STORAGE AND HANDLING SECTION
Other information store at 25° C (77° F) excursions permitted between 15°-30° C (59°-86° F) use by expiration date on package
INACTIVE INGREDIENT SECTION
corn starch, croscarmellose, hypromellose, microcrystalline cellulose,mineral oil, titanium dioxide
Products
- ASPIRIN EXTRA STRENGTH
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) | 461P5CJN6T | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
Complete SPL Sections
OTC - DO NOT USE SECTION
Do not use if you are allergic to aspirin or any other pain reliever/fever reducer
OTC - ASK DOCTOR 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 lost a lot of fluid due to vomiting or diarrhea you have not been drinking fluids
OTC - ASK DOCTOR/PHARMACIST 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
OTC - STOP USE 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
OTC - PREGNANCY OR BREAST FEEDING 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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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 while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor
STORAGE AND HANDLING SECTION
Other information store at 25° C (77° F) excursions permitted between 15°-30° C (59°-86° F) use by expiration date on package
INACTIVE INGREDIENT SECTION
corn starch, croscarmellose, hypromellose, microcrystalline cellulose,mineral oil, titanium dioxide
INDICATIONS & USAGE SECTION
Use for the temporary relief of minor aches and pains due to: headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor
OTC - PURPOSE SECTION
Pain Reliever/fever reducer
WARNINGS 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, asthmaaa9wheezing) 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.
OTC - ACTIVE INGREDIENT SECTION
In each Tablet Asprin 500 mg (NSAID*) *non-steroidal anti-inflammatory drug
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
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- dailymed/efc7d42a-241a-422d-bc08-be2f5f774b62/7d3ee158-5996-c9c6-e053-2991aa0a844a.xml
- XML SHA-256
- 449a0d5ada4dfe1272a34da683c08d1784b9bcf01c521124c01a89bc181eb162
- XML bytes
- 29814
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 382RLABEL.jpg | 2018-12-18 |
| otc | 7d3ee158-5996-c9c6-e053-2991aa0a844a.xml | 2018-12-18 |