Indications and uses
Temporarily relieves minor aches and pains due to Common cold headache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily relieves fever
Acetaminophen
- Manufacturer
- Trifecta Pharmaceuticals USA LLC
- Effective date
- 2024-06-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:13:33
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure17 sections
Dosage and administration
Do not take more than directed. See overdose warning Adults and children 12 years and older 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 use for more than 10 days unless directed by a doctor Children under 12 years of age Ask a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient
Acetaminophen USP, 500mg (in each tablet)
Purpose
Pain Releiver / Fever Reducer
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.
Uses
Temporarily relieves minor aches and pains due to
Common cold
headache
minor pain of arthritis
toothache
muscular aches
premenstrual and menstrual cramps
temporarily relieves fever
Warnings
Liver warning
This product contains acetaminophen. Sever liver damage may occur if you take
- more than 4000mg 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 ad seek medical medical help right away
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.
Keep out of reach of children
Keep out of reach of children
Directions
Do not take more than directed. See overdose warning
Adults and children 12 years and older
- 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 use for more than 10 days unless directed by a doctor
Children under 12 years of age
- Ask a doctor
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 a sign of a serious condition
If pregnant or breast-feeding
Ask a health professional before use
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 cretical for adults as well as children even if you do not notice symptoms.
Other Information
- Store at 20ºC - 25ºC (68ºF - 77ºF)
- Avoid high humidity
- See end panel for expiration date and lot number
Inactive Ingredients
hydroxypropyl methyl cellulose, polyethylene glycol, povidone K-30, Pregelatinized starch, Sodium starch glycoate, Stearic Acid
Questions or Comments?
Call 1-888-296-9067
Distributed By:
Distributed By:
Trifecta Pharmaceuticals USA®
Ft. Lauderdale, FL. 33301 USA
1-888-296-9067
*This product is not manufactured or distributed by the Johnson & Johnson Corporation, owner of the registered trademark Tylenol®
Reorder No. 2004
Made in the USA
Label
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69396-140-01 | Acetaminophen | 50 in 1 BOX | TABLET | 50 | 5 | |
| 69396-140-01 | Acetaminophen | 2 in 1 PACKET | TABLET | 2 | 5 | |
| 69396-140-03 | Acetaminophen | 10000 in 1 BAG | TABLET | 10000 | 5 | |
| 69396-140-03 | Acetaminophen | 2 in 1 PACKET | TABLET | 2 | 5 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- STEARIC ACID
- POLYETHYLENE GLYCOL, UNSPECIFIED
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- HYPROMELLOSE, UNSPECIFIED
- POVIDONE K30
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69396-140 | 69396-140-03, 69396-140-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STEARIC ACID | 4ELV7Z65AP | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | Trifecta Pharmaceuticals USA LLC | 026bf664-d598-73de-e063-6394a90a9206 | 2024-06-12 | Warnings | 69396-140-03 69396-140-01 69396-140 69396014003 69396014001 1ab8553b-2249-fd6f-e063-6294a90a684b 026bf664-d598-73de-e063-6394a90a9206 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.