Indications and uses
temporarily relieves minor aches and pains due to: headache toothache muscular aches the common cold backache minor pain of arthritis premenstrual and menstrual cramps temporarily reduces fever
Acetaminophen
- Manufacturer
- Amerisource Bergen | LNK International, Inc.
- Effective date
- 2023-03-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:34:57
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 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
Storage and handling
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Contacts and useful links#
Websitewww.mygnp.com
www.mygnp.com
www.mygnp.comLabel contents#
Full prescribing information#
Active ingredient (in each tablet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- headache
- toothache
- muscular aches
- the common cold
- backache
- minor pain of arthritis
- 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:
- blisters
- rash
- skin reddening
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
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.
In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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
- 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 at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide
*may contain this ingredient
Questions or comments?
1-800-426-9391
Principal display panel
GOOD
NEIGHBOR
PHARMACY®
Compare to Extra Strength Tylenol® active ingredient†
NDC 46122-649-71
EXTRA STRENGTH
Acetaminophen
Pain Reliever / Fever Reducer
50 Coated Tablets | 500 mg Each
Actual Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING
SATISFACTION GUARANTEED
GOOD NEIGHBOR PHARMACY
BRAND PRODUCTS
Distributed By
AmerisourceBergen
1 West First Avenue
Conshohocken, PA 19428
Questions or Concerns?
www.mygnp.com
†This product is not manufactured or
distributed by Johnson & Johnson
Corporation, owner of the registered
trademark Extra Strength Tylenol®.
50844 REV1220A53115
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 46122-649-71 | EA - Each | 46122-649 | ad5343d4-7f34-48c3-913d-3892ba6e8513 | 1 | 2021-08-05 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- STARCH, CORN
- D&C RED NO. 27 ALUMINUM LAKE
- D&C YELLOW NO. 10 ALUMINUM LAKE
- FD&C BLUE NO. 1 ALUMINUM LAKE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
- SUCRALOSE
- TALC
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 46122-649 | 46122-649-71 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 88e273c5-52c0-485e-a6f7-296401e00caf | 7a110e42-e545-496e-af65-efbbb6e6ff6e | 2023-03-07 | Warnings | 88e273c5-52c0-485e-a6f7-296401e00caf 7a110e42-e545-496e-af65-efbbb6e6ff6e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.