Indications and uses
• temporarily relieves minor aches and pains due to: • the common cold • headache • backache • minor pain of arthritis • muscular aches • toothache • premenstrual and menstrual cramps • temporarily reduces fever
• temporarily relieves minor aches and pains due to: • the common cold • headache • backache • minor pain of arthritis • muscular aches • toothache • 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, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor
• store at 20-25°C (68-77°F)
Acetaminophen 500 mg
Pain reliever/fever reducer
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
liver disease
taking the blood thinning drug warfarin
These could be signs of a serious condition.
ask a health professional before use.
Overdose warning: 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.
adults and children 12 years and over |
|
children under 12 years | ask a doctor |
carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid
*may contain one or more of these ingredients
1-888-287-1915
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49035-975-83 | EA - Each | 49035-975 | b8c6f42c-265d-44ca-8af2-1c87867732c6 | 1 | 2018-06-11 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 3 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 3 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 3 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49035-975 | 49035-975-83 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | 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 |
|---|---|---|---|---|---|---|
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / OPHTHALMIC | 0.5 %w/w | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE / ORAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | INJECTION / INTRAMUSCULAR | 0.2 %w/v | ||
| POVIDONES | POVIDONE | FZ989GH94E | SOLUTION / ORAL | 3000 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / ORAL | 305 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, ORALLY DISINTEGRATING / ORAL | 41 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 32 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 350 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOAP / TOPICAL | 6 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE / ORAL | 5785 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE, FOR SUSPENSION / ORAL | 1.7 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, CHEWABLE / ORAL | 180 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, ORALLY DISINTEGRATING / ORAL | 184 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | PELLET / ORAL | 162 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, DELAYED RELEASE / ORAL | 280 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, EXTENDED RELEASE / ORAL | 1472 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, SUGAR COATED / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CREAM / TOPICAL | 0.1 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 17 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, EXTENDED RELEASE / ORAL | 2150 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | SUSPENSION / ORAL | 150 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE / ORAL | 300 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, DELAYED RELEASE / ORAL | 216 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | DROPS / ORAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | SUSPENSION/ DROPS / OPHTHALMIC | 0.6 %w/v | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / SUBLINGUAL | 10 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, DELAYED RELEASE / ORAL | 79 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FOR SUSPENSION / ORAL | 2 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, COATED PELLETS / ORAL | 198 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, EXTENDED RELEASE / ORAL | 119.7 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, EXTENDED RELEASE / ORAL | 194 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, CHEWABLE / ORAL | 11.8 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE / ORAL | 1488 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 140 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | SOLUTION / OPHTHALMIC | 1.8 %w/v | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TROCHE / ORAL | 30 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, DELAYED RELEASE / ORAL | 713 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, EXTENDED RELEASE / ORAL | 184 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 |
|---|---|---|---|---|---|---|
| 9d350d27-ce39-4883-b142-1fac331d76a3 | 7cfc5ef0-58eb-431e-955e-d778e24e6f62 | 2022-12-06 | Warnings | 7cfc5ef0-58eb-431e-955e-d778e24e6f62 |
Adverse event summaries are temporarily unavailable. Other product information remains available.