OTC - ACTIVE INGREDIENT SECTION
Active Ingredient (in each tablet)
Aspirin 325 mg (NSAID)*
nonsteroidal antiinflammatory drug
Active Ingredient (in each tablet)
Aspirin 325 mg (NSAID)*
nonsteroidal antiinflammatory drug
Inactive Ingredients Hydroxypropylmethyl cellulose, polyethylene glycol, starch, talc, titanium dioxide
Purpose
Pain reliever / Fever reducer
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately
Uses provides temporary relief of: headache pain and fever of colds - muscle pain - toothache - minor pain of arthritis
Warnings
Do not use - if you have ever had an allergic reaction to any other pain relievers/fever reducers.
Reyes 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 or 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 sever allergic reaction which may include : facial swelling - asthma (wheezing) - shock - hives
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chances are higher if you are- 60 years of age or older - have had stomach ulcer bleeding problems - take a blood thinner (anticoagulant) or steroid drug - take other drugs containing prescription or non prescription NSAIDs (aspirin, ibuprofen, naproxen, others) - have 3 or more alcoholic drinks everyday while using this product - take more or for a longer time than directed
Directions - drink a full glass of water with each dose - Adults and children 12 years of age and over: take 1 to 2 tablets with water. Dosage may be repeated every 4 hours, not to exceed 12 tablets in 24 hours. Children under 12: consult a doctor
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 or complications during delivery
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42787-102-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bf3e-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42787-102-50 | Value PharmaPain RelieverExtra Strength | 16250 mg in 1 BOTTLE | TABLET | 16250 | 2 | |
| 42787-102-50 | Value PharmaPain RelieverExtra Strength | 1 in 1 CARTON | TABLET | 1 | 2 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Aspirin | ACTIVE INGREDIENT | R16CO5Y76E | 2 | |
| Aspirin | ACTIVE MOIETY | R16CO5Y76E | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 2 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | 2 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 42787-102 | 42787-102-50 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Aspirin | R16CO5Y76E | ACTIB |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POLYETHYLENE GLYCOLS | 3WJQ0SDW1A | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| talc | 7SEV7J4R1U | IACT |
| Titanium Dioxide | 15FIX9V2JP | IACT |
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 |
|---|---|---|---|---|---|---|
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | LOTION / TOPICAL | 0.1 %w/w | ||
| talc | TALC | 7SEV7J4R1U | GRANULE / ORAL | 322 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| talc | TALC | 7SEV7J4R1U | GRANULE, DELAYED RELEASE / ORAL | 525 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, DELAYED RELEASE / ORAL | 105 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| talc | TALC | 7SEV7J4R1U | TABLET, EXTENDED RELEASE / ORAL | 300 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | JELLY / TOPICAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| talc | TALC | 7SEV7J4R1U | GUM, CHEWING / BUCCAL | NA | ||
| talc | TALC | 7SEV7J4R1U | CAPSULE, COATED / ORAL | 87 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SYRUP / ORAL | 250 mg | ||
| talc | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| talc | TALC | 7SEV7J4R1U | TABLET, SUGAR COATED / ORAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| talc | TALC | 7SEV7J4R1U | ELIXIR / ORAL | 4.5 mg/5ml | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY / VAGINAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, DELAYED RELEASE / ORAL | 713 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| talc | TALC | 7SEV7J4R1U | TABLET, FOR SUSPENSION / ORAL | 24 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, ORALLY DISINTEGRATING / ORAL | 41 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SHAMPOO / TOPICAL | 3 %w/w | ||
| talc | TALC | 7SEV7J4R1U | SUSPENSION, EXTENDED RELEASE / ORAL | 46 mg | ||
| talc | TALC | 7SEV7J4R1U | TABLET, CHEWABLE / ORAL | 202 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE / ORAL | 5785 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, EXTENDED RELEASE / ORAL | 184 mg | ||
| talc | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE / ORAL | 349 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | INSERT / VAGINAL | 147 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | OINTMENT / TOPICAL | 5 %w/w | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| talc | TALC | 7SEV7J4R1U | OINTMENT / TOPICAL | 74.6 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, EXTENDED RELEASE / ORAL | 194 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| talc | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 56 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE, FOR SUSPENSION / ORAL | 1.7 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / ORAL | 305 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE / ORAL | 1488 mg |
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 |
|---|---|---|---|---|---|---|
| 615db3ad-3529-4e96-962a-96324d2c5c97 | ce54315f-02ae-49c4-b42f-79c17a4cc2d7 | 2012-11-15 | Warnings | 615db3ad-3529-4e96-962a-96324d2c5c97 ce54315f-02ae-49c4-b42f-79c17a4cc2d7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.