Indications and uses
temporarily reduces fever and relieves minor aches and pains caused by • headache • muscular aches • the common cold • toothache • premenstrual and menstrual cramps • backache • minor pain of arthritis
Acetaminophen - Rugby Laboratories
- Manufacturer
- Rugby Laboratories
- Effective date
- 2026-08-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- daily-update
- Hydrated at
- 2026-08-21 02:01:13
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#
Websitewww.major-rugby.com
www.major-rugby.com
www.major-rugby.comLabel contents#
Full prescribing information#
Drug Facts
Active ingredient (in each tablet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
temporarily reduces fever and relieves minor aches and pains caused by
• headache
• muscular aches
• the common cold
• toothache
• premenstrual and menstrual cramps
• backache
• minor pain of arthritis
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 are allergic to acetaminophen or any of the inactive ingredients in this product
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking 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.
Overdose warning:
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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
DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY:
RUGBY® LABORATORIES
INDIANAPOLIS, IN 46268
(800) 616-2471
*Rugby Laboratories is not affiliated with the owner of the registered trademark Tylenol®.
Rev. 01/26 R-29 Re-order No. 370597
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Rugby®
NDC 0536-1172-01
compare to active ingredient in extra strength Tylenol®*
extra strength
acetaminophen
acetaminophen 500 mg
extra strength pain reliever/fever reducer
aspirin free
100 tablets
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0305361172015 | GTIN-13: 0305361172015 EAN-13: 0305361172015 GTIN-12: 305361172015 UPC-A: 305361172015 GTIN storage (14 digits): 00305361172015 | 5427-100G-Rugby Lab-A4_LBL R54283.jpg |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-1172-01 | EA - Each | 0536-1172 | f30304ac-97a9-421a-a77c-c731f4437d25 | 1 | 2018-11-06 |
| 0536-1172-10 | EA - Each | 0536-1172 | 6e2522e7-6495-4491-b77c-0a609723c21b | 1 | 2018-11-06 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- STARCH, CORN
- POVIDONE K30
- STEARIC ACID
- SODIUM STARCH GLYCOLATE TYPE A POTATO
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0536-1172 | 0536-1172-10, 0536-1172-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2024-01-11 | full-release | 2026-06-01 00:07:02 |
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 | Rugby Laboratories | 76f10ee2-1d6a-097c-e053-2991aa0af526 | 2026-08-18 | Warnings | 0536-1172-01 0536-1172-10 0536-1172 00536117201 00536117210 5955a2e7-baa6-8b4e-e063-6394a90acbb7 76f10ee2-1d6a-097c-e053-2991aa0af526 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.