Indications and uses
temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Major Pharmaceuticals Acetaminophen Drug Facts
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2026-07-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- daily-update
- Hydrated at
- 2026-07-28 05:10:11
Label at a glance#
Productacetaminophen
Active ingredientACETAMINOPHEN
Label structure8 sections
Dosage and administration
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
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each caplet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you have ever had an allergic reaction to this product or any of its ingredients
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
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
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: 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.
Directions
- do not take more than directed (see overdose warning)
adults and children 12 years and over |
|
children under 12 years | ask a doctor |
Inactive ingredients
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
Questions or comments?
1-800-616-2471
Principal Display Panel
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Data Matrix | 0100368071343755210000000002<GS>170000010000000<GS> | 68071-3437-5.jpg |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6720-24 | EA - Each | 0904-6720 | 03f5fcf1-26d4-42a3-933a-efce614fe4a3 | 1 | 2018-09-05 |
| 0904-6720-40 | EA - Each | 0904-6720 | 4890ef93-88db-4a11-83fe-eeb3e19d935a | 1 | 2018-09-05 |
| 0904-6720-51 | EA - Each | 0904-6720 | 4b021127-08c3-477c-a5e5-6a4adf656ed3 | 1 | 2018-09-05 |
| 0904-6720-59 | EA - Each | 0904-6720 | db281eca-a672-463a-8b75-a43da8c0bad5 | 1 | 2018-10-11 |
| 0904-6720-60 | EA - Each | 0904-6720 | d6803552-927d-4ca4-a9fe-4df4f02e9cca | 1 | 2018-12-13 |
| 0904-6720-80 | EA - Each | 0904-6720 | 2fe5fcfa-ffba-49d8-bb69-f7e30364e6f5 | 1 | 2018-08-13 |
Products#
Every source-derived product name is available through these pages.
- acetaminophen
- CARNAUBA WAX
- STARCH, CORN
- HYPROMELLOSE, UNSPECIFIED
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- STEARIC ACID
- CROSCARMELLOSE SODIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68071-3437 | 68071-3437-5, 68071-3437-2, 68071-3437-1, 68071-3437-3 |
| 0904-6720 |
Ingredients#
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 |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 4 | 2026-03-30 | full-release | 2026-06-01 01:52:03 |
| 3 | 2026-01-13 | monthly-update | 2026-06-03 17:52:40 |
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 |
|---|---|---|---|---|---|---|
| acetaminophen | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | fdb7331a-d029-8b2a-e053-6294a90adfcd | 2026-07-24 | Warnings | 68071-3437-2 68071-3437-3 68071-3437-1 68071-3437-5 68071-3437 68071343701 68071343702 68071343703 68071343705 575e7de2-8194-8e73-e063-6394a90a1d8b fdb7331a-d029-8b2a-e053-6294a90adfcd |
| acetaminophen | ACETAMINOPHEN | Major Pharmaceuticals | 020fa486-31f0-4e0c-84d3-5b3aaded1eeb | 2026-02-13 | Warnings | 0904-6720 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.