Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet) Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purpose PAIN RELIEVER
ASA D-R 81MG 349R
- Set ID
- 70d8ba6c-8dfe-402a-817d-22544141d160
- Manufacturer
- Time-Cap Labs, Inc
- Effective date
- 2018-12-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 22:57:41
Key Label Information
Uses
INDICATIONS & USAGE 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
Warnings
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 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) 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 - 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.
Directions And Dosage
DOSAGE & ADMINISTRATION 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
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
Inactive ingredients anhydrous lactose, black iron oxide, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD-C red 40 aluminum lake, FD-C yellow 6 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, potassium hydroxide, propylene glycol, shellac, simethicone, sodium hydroxide, sodium lauryl sulfate, triethyl citrate
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
ASPIRIN 81MG PEACH TABLETS
Products
- Aspirin Delayed Release
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS LACTOSE | 3SY5LH9PMK | IACT |
| FERROSOFERRIC OXIDE | XM0M87F357 | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | NX76LV5T8J | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| POTASSIUM HYDROXIDE | WZH3C48M4T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SHELLAC | 46N107B71O | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TRIETHYL CITRATE | 8Z96QXD6UM | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
Complete SPL Sections
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet) Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purpose PAIN RELIEVER
INDICATIONS & USAGE 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
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 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) 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 - 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 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 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
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
Inactive ingredients anhydrous lactose, black iron oxide, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD-C red 40 aluminum lake, FD-C yellow 6 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, potassium hydroxide, propylene glycol, shellac, simethicone, sodium hydroxide, sodium lauryl sulfate, triethyl citrate
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
ASPIRIN 81MG PEACH TABLETS
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
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- dailymed/70d8ba6c-8dfe-402a-817d-22544141d160/7cff0ad4-677a-03f7-e053-2a91aa0af7ae.xml
- XML SHA-256
- 86a95ecbb31d5c172b29672c703d7ba8b7604b29d5766283c45eab7246d8e015
- XML bytes
- 29604
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 349R.jpg | 2018-12-15 |
| otc | 7cff0ad4-677a-03f7-e053-2a91aa0af7ae.xml | 2018-12-15 |