Indications and uses
Temporarily reduces fever and relieves minor aches and pains due to: headache muscular aches the common cold toothache backache minor pain of arthritis premenstrual and menstrual cramps
5427-Major
- Manufacturer
- REMEDYREPACK INC.
- Effective date
- 2026-10-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- daily-update
- Hydrated at
- 2026-10-30 01:02:29
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure10 sections
Dosage and administration
do not take more than directed (see overdose warning) adults and children 12 years and over: • take 2 tablets every 6 hours while symptoms last • do not take more than 6 tablets in 24 hours, unless directed by a doctor • do not take 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#
Drug Facts
Active ingredient (in each tablet)
Acetaminophen 500 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/ fever reducer
Uses
Temporarily reduces fever and relieves minor aches and pains due to:
- headache
- muscular aches
- the common cold
- toothache
- backache
- minor pain of arthritis
- premenstrual and menstrual cramps
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.
OTC - DO NOT USE SECTION
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 are allergic to acetaminophen or any of the inactive ingredients in this product
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you haveliver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin
OTC - STOP USE SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
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:
• take 2 tablets every 6 hours while symptoms last
• do not take more than 6 tablets in 24 hours, unless directed by a doctor
• do not take for more than 10 days unless directed by a doctor
children under 12 years:ask a doctor
Other information
store in a dry place at 15° – 30°C (59° – 86°F).
Inactive ingredients
corn starch, povidone, sodium starch glycolate, stearic acid.
Questions or comments?
Call 1-800-231-4670
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol®.
Rev. 04/26 M-29 Re-order No. 700923
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DRUG: Acetaminophen
GENERIC: Acetaminophen
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 70518-4783-0
COLOR: white
SHAPE: ROUND
SCORE: Two even pieces
SIZE: 12 mm
IMPRINT: 54;27
PACKAGING: 120 in 1 BOTTLE, PLASTIC
ACTIVE INGREDIENT(S):
- ACETAMINOPHEN 500mg in 1
INACTIVE INGREDIENT(S):
- STARCH, CORN
- STEARIC ACID
- POVIDONE K30
- SODIUM STARCH GLYCOLATE TYPE A POTATO
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6730-59 | EA - Each | 0904-6730 | 8c088197-3332-449d-8a4e-f973da83c10a | 1 | 2018-10-11 |
| 0904-6730-60 | EA - Each | 0904-6730 | 0af87dfc-0b3e-49aa-ab5b-8f87b4fb2ed2 | 1 | 2018-12-13 |
| 0904-6730-61 | EA - Each | 0904-6730 | 36f619ef-5650-4897-beb0-7f747d554803 | 1 | 2018-10-11 |
| 0904-6730-80 | EA - Each | 0904-6730 | 3b5af9b2-1de7-4955-ba59-3c125a3488d2 | 1 | 2018-10-11 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- STARCH, CORN
- STEARIC ACID
- POVIDONE K30
- SODIUM STARCH GLYCOLATE TYPE A POTATO
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70518-4783 | 70518-4783-0 |
| 0904-6730 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
Source Document#
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.