Indications and uses
Use for temporary relief of minor aches and pains due to: ° headache ° muscular aches ° backache ° arthritis ° the common cold ° toothache ° menstrual cramps ° temporarily reduces fever
Acetaminophen
- Manufacturer
- Rebel Distributors Corp
- Effective date
- 2011-02-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:27:18
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
Do not take more than directed ° adults and children 12 years and older, take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours. ° children under 12, consult a doctor before use.
Storage and handling
For your protection, this bottle has an imprinted Safety Seal under cap. Do not use if Safety Seal is broken or missing. Store at room temperature. Questions? To report an adverse drug effect, contact 1-800-795-9775.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Acetaminophen 325mg
Acetaminophen 500mg
Keep Out of Reach of Children
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose get medical help or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as children, even if you do not notice symptoms or signs.
Uses
Use for temporary relief of minor aches and pains due to:
° headache ° muscular aches ° backache ° arthritis ° the common cold ° toothache ° menstrual cramps ° temporarily reduces fever
Warnings
Alcohol Warning: If you consume 3 or more alcoholic beverages every day, ask your doctor whether you should take Acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.
Do not use with any other product containing Acetaminophen or if you have ever had an allergic reaction to pain relievers/fever reducers.
Stop use and ask a doctor if
° new symptoms occur ° redness or swelling is present ° pain gets worse or lasts more than 10 days ° fever gets worse or lasts more than 3 days.
If pregnant or breast-feeding, ask a doctor before use.
Directions
Do not take more than directed
° adults and children 12 years and older, take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours. ° children under 12, consult a doctor before use.
Other Information
For your protection, this bottle has an imprinted Safety Seal under cap. Do not use if Safety Seal is broken or missing.
Store at room temperature.
Questions? To report an adverse drug effect, contact 1-800-795-9775.
Inactive ingredients
Crospovidone, Povidone, Pregelatinized Starch, Stearic Acid.
Distributed by:
Plus PharmaCommack
New York 11725
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
Principal Display Panel
Principal Display Panel
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-007-00 | Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 21695-007-30 | Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 21695-007-60 | Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 21695-008-00 | Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 21695-008-14 | Acetaminophen | 14 in 1 BOTTLE | TABLET | 14 | 1 | |
| 21695-008-15 | Acetaminophen | 15 in 1 BOTTLE | TABLET | 15 | 1 | |
| 21695-008-20 | Acetaminophen | 20 in 1 BOTTLE | TABLET | 20 | 1 | |
| 21695-008-30 | Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 21695-008-50 | Acetaminophen | 50 in 1 BOTTLE | TABLET | 50 | 1 | |
| 21695-008-60 | Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 21695-007 | ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 3 package rows | 20110223_457a2359-e7bc-4d23-a064-439989aa208d.zip |
| 21695-008 | ACETAMINOPHEN TABLET [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 7 package rows | 20110223_457a2359-e7bc-4d23-a064-439989aa208d.zip |
DailyMed Billing Units#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- CROSPOVIDONE
- POVIDONE
- STARCH, CORN
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 21695-007 | 21695-007-30, 21695-007-60, 21695-007-00 |
| 51645-703 | |
| 21695-008 | 21695-008-14, 21695-008-15, 21695-008-20, 21695-008-30, 21695-008-50, 21695-008-60, 21695-008-00 |
| 51645-706 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CROSPOVIDONE | 68401960MK | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CROSPOVIDONE | 68401960MK | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
Source Document#
Inactive ingredient matches#
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 | POVIDONE | FZ989GH94E | SUSPENSION / OPHTHALMIC | 1.8 %w/v | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 350 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, DELAYED RELEASE / ORAL | 53 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | SUSPENSION / ORAL | 20 mg/5ml | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FOR SUSPENSION / ORAL | 2 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | IMPLANT / SUBCUTANEOUS | 6 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, EXTENDED RELEASE / ORAL | 101 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE / ORAL | 300 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 32 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | INSERT / VAGINAL | 147 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, COATED PELLETS / ORAL | 10.03 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, DELAYED RELEASE / ORAL | 713 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, DELAYED RELEASE / ORAL | 80 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, DELAYED RELEASE / ORAL | 216 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, COATED / ORAL | 49.2 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | SOLUTION / ORAL | 3000 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE / ORAL | 5785 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | INJECTION / INTRAMUSCULAR | 0.2 %w/v | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET / SUBLINGUAL | 6 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | SUSPENSION/ DROPS / OPHTHALMIC | 0.6 %w/v | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, ORALLY DISINTEGRATING / ORAL | 15.03 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TROCHE / ORAL | 30 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, EXTENDED RELEASE / ORAL | 184 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | DROPS / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 17 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, CHEWABLE / ORAL | 180 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg |
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| 457a2359-e7bc-4d23-a064-439989aa208d | 457a2359-e7bc-4d23-a064-439989aa208d | 2011-02-14 | Warnings | 457a2359-e7bc-4d23-a064-439989aa208d 457a2359-e7bc-4d23-a064-439989aa208d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.