Indications and uses
temporarily relieves minor aches and pains due to: headache backache toothache the common cold minor pain of arthritis muscular aches premenstrual and menstrual cramps temporarily reduces fever
temporarily relieves minor aches and pains due to: headache backache toothache the common cold minor pain of arthritis muscular aches premenstrual and menstrual cramps temporarily reduces fever
store 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Acetaminophen
Pain reliever/fever reducer
Liver warning: This product contains acetaminophen. The maximum daily dosse of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take:
Ask a doctor before use if you have
liver disease.
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damamge. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Inactive Ingredients
Polyvinylpyrrolidone, pregelatinized starch, sodium starch glycolate, stearic acid
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61715-052-01 | 2020-02-15 | C162847 | 48780-1 | 9d75b9d0-3e4d-f424-e053-dadaa90a57ce | DRUG FACTS |
| 61715-052-08 | 2020-02-15 | C162847 | 48780-1 | 9d75b9d0-3e4d-f424-e053-dadaa90a57ce | DRUG FACTS |
| 61715-052-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3e4d-f424-e053-dadaa90a57ce | DRUG FACTS |
| 61715-052-08 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3e4d-f424-e053-dadaa90a57ce | DRUG FACTS |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61715-052 | 61715-052-08, 61715-052-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| POVIDONE K30 | U725QWY32X | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| STEARIC ACID | 4ELV7Z65AP | 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 |
|---|---|---|---|---|---|---|
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | POWDER, FOR SOLUTION / ORAL | 2832 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 15 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | LOZENGE / ORAL | 700 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE / ORAL | 540 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | FILM, EXTENDED RELEASE / TRANSDERMAL | 16 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, DELAYED RELEASE / ORAL | 227 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TROCHE / ORAL | 175 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | PELLET / ORAL | 24 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / SUBLINGUAL | 30 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | AEROSOL, FOAM / TOPICAL | 1.9 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | POWDER / ORAL | 378 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / BUCCAL | 1 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SOLUTION / ORAL | 300 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, DELAYED RELEASE / ORAL | 516 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOAP / TOPICAL | 6 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, COATED / ORAL | 160 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | GRANULE, EFFERVESCENT / ORAL | 40 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 12 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / ORAL | 2828 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SOLUTION/ DROPS / OPHTHALMIC | 4 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, ORALLY DISINTEGRATING / ORAL | 71 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, FOR SUSPENSION / ORAL | 462 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SOLUTION / OPHTHALMIC | 42 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SUSPENSION / ORAL | 148 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 178 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | FILM / SUBLINGUAL | 7 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | POWDER, FOR SUSPENSION / ORAL | 257 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | GRANULE, FOR SUSPENSION / ORAL | 120 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SUSPENSION / OPHTHALMIC | 14 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, DELAYED RELEASE / ORAL | 80 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, DELAYED RELEASE PARTICLES / ORAL | 70 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 45 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, CHEWABLE / ORAL | 245 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, LIQUID FILLED / ORAL | 101 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SUSPENSION, EXTENDED RELEASE / ORAL | 474 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | GRANULE / ORAL | 202 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 |
|---|---|---|---|---|---|---|
| 7a7eb443-1cee-4e90-bec2-a34772314547 | 7c2bfaa9-e30f-42f7-b38d-d7ad53e72744 | 2013-06-26 | Warnings | 7a7eb443-1cee-4e90-bec2-a34772314547 7c2bfaa9-e30f-42f7-b38d-d7ad53e72744 |
Adverse event summaries are temporarily unavailable. Other product information remains available.