INDICATIONS & USAGE SECTION
Uses:
temporarily relieves minor aches and pains
associated with: • backache • toothache • colds • headaches • muscular aches • menstrual cramps • minor arthritis pain
Uses:
temporarily relieves minor aches and pains
associated with: • backache • toothache • colds • headaches • muscular aches • menstrual cramps • minor arthritis pain
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.
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.
Do not use:• if you are allergic to aspirin • with any other pain reliever/fever reducer • if you have ever had an allergic reaction to any
other pain reliever/fever reducer
• for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor
• with any other product containing acetaminophen
Ask a doctor before using if you have:
• asthma • gastric ulcers • bleeding problems • stomach problems (such as heartburn, upset stomach or stomach pain)
Ask a doctor or pharmacist before use if you are taking a prescription drug for: • anticoagulation (thinning of blood)
• diabetes • gout • arthritis
Stop use and ask a doctor if: • ringing in the ears or loss of hearing occurs • pain or fever persists or gets worse
• new symptoms occur • redness or swelling is present
When using this product do not exceed
recommended dose.
Directions:
Adults and children 12 years of age and older take 2 tablets
every 4 hours for pain as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.
Children under 12 years consult a doctor.
Inactive Ingredients:
FD&C yellow #6, magnesium stearate,
microcrystalline cellulose, povidone,
starch, and stearic acid.
ACTIVE INGREDIENT-ACETAMINOPHEN 110 MG, ASPIRIN 162 MG,CAFFEINE 32.4MG, SALICYLAMIDE 152 MG
PAIN RELIEVER, FEVER REDUCER WITH ADJUVANT
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| ASPIRIN | ACTIVE INGREDIENT | R16CO5Y76E | 1 | |
| SALICYLAMIDE | ACTIVE INGREDIENT | EM8BM710ZC | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| ASPIRIN | ACTIVE MOIETY | R16CO5Y76E | 1 | |
| SALICYLAMIDE | ACTIVE MOIETY | EM8BM710ZC | 1 | |
| CAFFEINE | INACTIVE INGREDIENT | 3G6A5W338E | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | 1 | |
| STARCH, 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 |
|---|---|
| 69103-2507 | 69103-2507-5, 69103-2507-6 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CAFFEINE | 3G6A5W338E | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
| SALICYLAMIDE | EM8BM710ZC | 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 | INSERT / VAGINAL | 147 mg | ||
| CAFFEINE | CAFFEINE | 3G6A5W338E | SOLUTION / OPHTHALMIC | 2 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | FILM / SUBLINGUAL | 7 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE / ORAL | 29520 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET / SUBLINGUAL | 0.11 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, SUGAR COATED / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SUSPENSION, EXTENDED RELEASE / ORAL | 474 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION, EXTENDED RELEASE / ORAL | 1120 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE / ORAL | 540 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, EXTENDED RELEASE / ORAL | 194 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | GRANULE, EFFERVESCENT / ORAL | 40 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, DELAYED RELEASE / ORAL | 227 mg | ||
| CAFFEINE | CAFFEINE | 3G6A5W338E | GRANULE / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TROCHE / ORAL | 300 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SUSPENSION / ORAL | 148 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | CAPSULE, EXTENDED RELEASE / ORAL | 0.26 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SOLUTION / ORAL | 300 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IMPLANT / INTRAVITREAL | 1.66 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET / BUCCAL | 0.11 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SOLUTION / TOPICAL | 0.06 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | POWDER / TOPICAL | NA | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | INJECTION / INTRAMUSCULAR | 0.59 %w/v | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | POWDER, FOR SUSPENSION / ORAL | 257 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, DELAYED RELEASE / ORAL | 216 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SOLUTION/ DROPS / OPHTHALMIC | 4 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, CHEWABLE / ORAL | 180 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | LIQUID / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, FILM COATED / ORAL | 1.68 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 12 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, DELAYED RELEASE / ORAL | 3 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FOR SUSPENSION / ORAL | 20100 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, COATED / ORAL | 7.93 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / ORAL | 2828 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, FILM COATED / ORAL | 245 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA |
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 |
|---|---|---|---|---|---|---|
| f18bebf2-192a-658f-e053-2a95a90a5012 | 54b10f1d-8988-4f2f-88f8-49ee9d2cb96e | 2023-01-05 | Warnings | f18bebf2-192a-658f-e053-2a95a90a5012 54b10f1d-8988-4f2f-88f8-49ee9d2cb96e |
Adverse event summaries are temporarily unavailable. Other product information remains available.