Indications and uses
for the temporary relief of minor aches and pains or as recommended by your doctor.
Chewable Adult Low Dose Aspirin
- Manufacturer
- Raritan Pharmaceuticals Inc
- Effective date
- 2021-01-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:36:44
Label at a glance#
ProductChewable Adult Low Dose Aspirin
Active ingredientASPIRIN
Label structure8 sections
Dosage and administration
▪ 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
▪ store at room temperature ▪ see end flap for expiration date and lot number
Label contents#
Full prescribing information#
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.
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 over
- 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
- this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
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
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
- redness or swelling is present
- new symptoms occur
- ringing in the ears or loss of hearing occurs
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, 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: consult a doctor
Other information
- store at room temperature
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, dextrose, FD&C yellow #6 aluminum lake, flavors, maltodextrin, sucralose.
Principal Display Panel
DRxChoice
compare to Bayer® Chewable Low Dose Aspirin active ingredients**
NDC 68163-081-91
low dose
CHEWABLE ASPIRIN
81 mg tablets
pain reliever (NSAID)
orange flavor
aspirin regimen
36 Chewable Tablets
3 bottles - 36 tablets each
value pack
DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING
**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Chewable Low Dose Aspirin.
GLUTEN-FREE (less than 20ppm gluten. If you have specific dietary needs you should consult a doctor before consuming this product.
Distributed By:
Raritan Pharmaceuticals Inc
8 Joanna Court
ASPIRIN Display artwork-1
ASPIRIN artwork Label Display-2
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7724692-1155-4cc8-a415-22f5fc4aec35 | Product name | 6 | 20220216 |
| bde672ba-4805-28d0-1986-73543d41b412 | Product name | 2 | 20210201 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 9425d234-4ae1-4b53-adc6-8cc7af6dd657 | Product name | 1 | 20150929 |
| 2a21311a-89e2-0e83-2ebd-117f9798b2b2 | Product name | 1 | 20140508 |
| 9007e8a7-ff50-f9b9-7945-f2a1deadd94e | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68163-081-91 | 2023-01-30 | C162847 | 48780-1 | f386c649-e26f-0266-e053-dadaa90a7c1a | DRx. Choice Chewable Aspirin |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68163-081-91 | Chewable Adult Low Dose Aspirin | 36 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 36 | 3 | |
| 68163-081-91 | Chewable Adult Low Dose Aspirin | 3 in 1 CARTON | TABLET, CHEWABLE | 3 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ASPIRIN | ACTIVE INGREDIENT | R16CO5Y76E | 1 | |
| ASPIRIN | ACTIVE MOIETY | R16CO5Y76E | 1 | |
| DEXTROSE | INACTIVE INGREDIENT | IY9XDZ35W2 | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 |
Products#
Every source-derived product name is available through these pages.
- Chewable Adult Low Dose Aspirin
- Aspirin
- DEXTROSE, UNSPECIFIED FORM
- STARCH, CORN
- FD&C YELLOW NO. 6
- MALTODEXTRIN
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68163-081 | 68163-081-91 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASPIRIN | R16CO5Y76E | ACTIB |
| DEXTROSE, UNSPECIFIED FORM | IY9XDZ35W2 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | INJECTION, SOLUTION / INTRATHECAL | 1925 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, DELAYED RELEASE / ORAL | 2 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, CHEWABLE / ORAL | 0.41 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | SOLUTION / INTRAVENOUS | 5.05 %w/v | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | POWDER, FOR SUSPENSION / ORAL | 400 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | TABLET / ORAL | 183.66 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE / ORAL | 7 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | SUSPENSION / ORAL | 6040 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | FILM / SUBLINGUAL | 0.03 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE / ORAL | 5.4 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, DELAYED RELEASE / ORAL | 216 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, CHEWABLE / ORAL | 180 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE, FOR SUSPENSION / ORAL | 23 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LIQUID / ORAL | 0.2 mg/1ml | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | LOZENGE / ORAL | 175 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, DELAYED RELEASE / ORAL | 713 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET / SUBLINGUAL | 12 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | CAPSULE / ORAL | 200 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | MOUTHWASH / BUCCAL | 0.01 mg/1ml | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | TABLET / SUBLINGUAL | 115.78 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, DELAYED RELEASE / ORAL | 0.02 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | FILM, SOLUBLE / ORAL | 19 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | INJECTION / INTRAMUSCULAR | 5 %w/v | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, FOR SUSPENSION / ORAL | 65 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SUSPENSION / ORAL | 6 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SPRAY, METERED / NASAL | 2 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | INSERT / VAGINAL | 147 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LOTION / TOPICAL | NA | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, ORALLY DISINTEGRATING / ORAL | 12 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | POWDER, FOR SOLUTION / ORAL | NA | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | SOLUTION / ORAL | 1451 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION / ORAL | 11 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | GEL / TOPICAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET / SUBLINGUAL | 1 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / ORAL | 75.3 mg/15ml | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET / ORAL | 45 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | INJECTION, SOLUTION / INTRAVENOUS | 51.7 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | TABLET, EXTENDED RELEASE / ORAL | 103.95 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOAP / TOPICAL | 0.2 %w/w | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | SPRAY, METERED / NASAL | 50 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SPRAY / NASAL | 2 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | DROPS / ORAL | 0.2 mg/1ml | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, EXTENDED RELEASE / ORAL | 4.59 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | TABLET, CHEWABLE / ORAL | 1286 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | LOZENGE / BUCCAL | NA | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | GRANULE, FOR SUSPENSION / ORAL | 952 mg |
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 |
|---|---|---|---|---|---|---|
| 496b3bd2-85c7-42cd-9b35-893fa9641079 | 6bcbff93-c2b7-4ffa-bd41-5e6bc08f7ff9 | 2021-01-08 | Warnings | 496b3bd2-85c7-42cd-9b35-893fa9641079 6bcbff93-c2b7-4ffa-bd41-5e6bc08f7ff9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.