INDICATIONS & USAGE SECTION
Uses:
for temporary relief of mild to moderate pain
associated with headache.
Uses:
for temporary relief of mild to moderate pain
associated with headache.
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 SPECIFICALLY
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. Prompt medical attention is
critical for adults as well as for children
even if you do not notice any signs or
symptoms.
Warnings:
Reye's syndrome: Children and teenagers should not
use this medicine for chicken pox or u symptoms
before a doctor is consulted about Reye's syndrome, a
rare but serious illness reported to be associated with
aspirin.
Allergy Alert: Do not take this product if after
taking a pain reliever or fever reducer you ever had • hives • facial swelling • asthma • shock
Alcohol Warning: If you consume 3 or more
alcoholic drinks every day, ask your doctor whether you
should take acetaminophen and aspirin or other pain
relievers/fever reducers. Acetaminophen and aspirin may
cause liver damage and stomach bleeding.
Ask a doctor before use if you have: • the worst headache of your life • ulcers
• fever and sti neck • asthma
• bleeding problems • liver disease
• renal disease
When using this product:
• limit the use of caffeine containing medications,
foods, or beverages while taking this product
because too much caFFeine may cause
nervousness, sleeplessness, irritability and,
occasionally, rapid heart beat.
Stop use and ask a doctor if:
• headache pain worsens or continues for more than 48 hours
• new or unexpected symptoms occur
• ringing in the ears or loss of hearing occur
Directions:
Adults and children 12 years of age, no to exceed 8 tablets in 24 hours, or as directed by a doctor.
Children under 12 years: Do not give to children under 12 unless directed by a doctor.
Inactive Ingredients:
cellulose, pharmaceutical glaze,
povidone, starch, stearic acid and talc
USP.
ACTIVE INGREDIENT-ACETAMINOPHEN 250 MG, ASPIRIN 250 MG,CAFFEINE 65 mg
PAIN RELIEVER, FEVER REDUCER WITH ADJUVANT
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| ASPIRIN | ACTIVE INGREDIENT | R16CO5Y76E | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| ASPIRIN | ACTIVE MOIETY | R16CO5Y76E | 1 | |
| CAFFEINE | INACTIVE INGREDIENT | 3G6A5W338E | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A CORN | INACTIVE INGREDIENT | AG9B65PV6B | 1 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69103-2533 | 69103-2533-5, 69103-2533-6 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CAFFEINE | 3G6A5W338E | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 |
|---|---|---|---|---|---|---|
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / ORAL | 2828 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SUSPENSION / ORAL | 4441 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, CHEWABLE / ORAL | 245 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | GRANULE / ORAL | 202 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / BUCCAL | 1 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TROCHE / ORAL | 300 mg | ||
| CAFFEINE | CAFFEINE | 3G6A5W338E | SPRAY, METERED / NASAL | 10 mg/1ml | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SYSTEM / TRANSDERMAL | 15 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 178 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | POWDER, FOR SOLUTION / ORAL | 2832 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | LOZENGE / ORAL | 700 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 144 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / SUBLINGUAL | 30 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, COATED / ORAL | 160 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SUSPENSION / OPHTHALMIC | 14 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, EXTENDED RELEASE / ORAL | 368 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SOLUTION / ORAL | 300 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SOLUTION/ DROPS / OPHTHALMIC | 4 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | AEROSOL, FOAM / TOPICAL | 1.9 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | CAPSULE / ORAL | 5785 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | GRANULE, EFFERVESCENT / ORAL | 40 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TROCHE / ORAL | 175 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, DELAYED RELEASE / ORAL | 516 mg | ||
| CAFFEINE | CAFFEINE | 3G6A5W338E | GRANULE / ORAL | NA | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | POWDER / ORAL | 378 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, DELAYED RELEASE PARTICLES / ORAL | 70 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 15 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IMPLANT / INTRAVITREAL | 1.66 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE / ORAL | 2169 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE / ORAL | 540 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE / ORAL | 29520 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING / ORAL | 1800 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | TABLET, DELAYED RELEASE / ORAL | 713 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 |
|---|---|---|---|---|---|---|
| f18ec92d-392b-bfa5-e053-2a95a90a4545 | 715d92bc-7df2-4f7d-bc91-305c4c4c54e4 | 2023-01-05 | Warnings | f18ec92d-392b-bfa5-e053-2a95a90a4545 715d92bc-7df2-4f7d-bc91-305c4c4c54e4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.