Indications and uses
temporarily relieves minor aches and pains due to: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
temporarily relieves minor aches and pains due to: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
do not take more than directed (see Overdose warning ) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours do not take for more than 10 days unless directed by a doctor children under 12 years: do not use
store between 68-77°F (20-25°C)
Drug Facts
Acetaminophen 500 mg
Pain reliever/fever reducer
This product contains acetaminophen. Severe liver damage may occur if you take:
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
corn starch, croscarmellose sodium1, hypromellose1, lactose monohydrate1, magnesium stearate1, maltodextrin1, medium-chain triglycerides1, mineral oil1, polydextrose1, polyethylene glycol1, polyvinyl alcohol1, povidone, purified water1, sodium starch glycolate1, stearic acid1, talc1, titanium dioxide
1 contains one or more of these ingredients
Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)
Proudly distributed by Circle K Stores Inc.
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| Crospovidone | INACTIVE INGREDIENT | 68401960MK | 1 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| Maltodextrin | INACTIVE INGREDIENT | 7CVR7L4A2D | 1 | |
| Mineral Oil | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| Polydextrose | INACTIVE INGREDIENT | VH2XOU12IE | 1 | |
| Povidones | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| Sodium Starch Glycolate Type A Corn | INACTIVE INGREDIENT | AG9B65PV6B | 1 | |
| Sodium Starch Glycolate Type A Potato | INACTIVE INGREDIENT | 5856J3G2A2 | 1 | |
| Starch, Corn | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| Stearic Acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 66715-5837 | 66715-5837-4 |
| 66715-5737 | 66715-5737-4 |
| 66715-5637 | 66715-5637-4 |
Every source-derived ingredient row is available through these pages.
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 | OINTMENT / TOPICAL | 5 %w/w | ||
| Talc | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE / ORAL | 349 mg | ||
| Povidones | POVIDONE | FZ989GH94E | SUSPENSION/ DROPS / OPHTHALMIC | 0.6 %w/v | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | OINTMENT / TOPICAL | 9938 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| Maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | TABLET, EXTENDED RELEASE / ORAL | 3239 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | TABLET, COATED / ORAL | 1.5 mg | ||
| Talc | TALC | 7SEV7J4R1U | ELIXIR / ORAL | 4.5 mg/5ml | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | OINTMENT / OPHTHALMIC | 59.5 %w/w | ||
| Talc | TALC | 7SEV7J4R1U | POWDER, FOR SUSPENSION / ORAL | 735 mg | ||
| Maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | TABLET, COATED / ORAL | 5.6 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| Talc | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 56 mg | ||
| Povidones | POVIDONE | FZ989GH94E | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 350 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | LOTION / TOPICAL | 0.1 %w/w | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| Talc | TALC | 7SEV7J4R1U | DROPS / ORAL | NA | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED PELLETS / ORAL | 3.32 mg | ||
| Maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | FILM, SOLUBLE / ORAL | 19 mg | ||
| Polydextrose | POLYDEXTROSE | VH2XOU12IE | TABLET, EXTENDED RELEASE / ORAL | 22 mg | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | INSERT / VAGINAL | 147 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| Talc | TALC | 7SEV7J4R1U | CAPSULE, EXTENDED RELEASE / ORAL | 5119 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | TABLET, EXTENDED RELEASE / ORAL | 184 mg | ||
| Talc | TALC | 7SEV7J4R1U | TABLET, FOR SUSPENSION / ORAL | 24 mg | ||
| Povidones | POVIDONE | FZ989GH94E | INJECTION / INTRAMUSCULAR | 0.2 %w/v | ||
| Maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | SOLUTION / ORAL | 1451 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | TABLET, CHEWABLE / ORAL | 180 mg | ||
| Povidones | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| Talc | TALC | 7SEV7J4R1U | TABLET / RECTAL | 32.4 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | PASTE / TOPICAL | 47.5 %w/w | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | SYSTEM / TOPICAL | 54 mg | ||
| Povidones | POVIDONE | FZ989GH94E | SUSPENSION / OPHTHALMIC | 1.8 %w/v | ||
| Starch, Corn | STARCH, CORN | O8232NY3SJ | CAPSULE, EXTENDED RELEASE / ORAL | 194 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| Talc | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| Talc | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| Talc | TALC | 7SEV7J4R1U | TABLET, SUGAR COATED / ORAL | NA | ||
| Polydextrose | POLYDEXTROSE | VH2XOU12IE | TABLET / ORAL | 20 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | SUSPENSION / TOPICAL | 82 %w/w | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | CAPSULE / ORAL | 120 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 |
|---|---|---|---|---|---|---|
| 3922e493-940d-4619-801e-e96d4598eee6 | 441fd449-31b3-4f34-a0f2-a8979c2e80f7 | 2020-10-05 | Warnings | 3922e493-940d-4619-801e-e96d4598eee6 441fd449-31b3-4f34-a0f2-a8979c2e80f7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.