Indications and uses
temporarily relieves minor aches and pains due to: ▪ headache ▪ backache ▪ toothache ▪ the common cold ▪ minor pain of arthritis ▪ muscular aches ▪ premenstrual and menstrual cramps • temporarily reduces fever
temporarily relieves minor aches and pains due to: ▪ headache ▪ backache ▪ toothache ▪ the common cold ▪ minor pain of arthritis ▪ muscular aches ▪ premenstrual and menstrual cramps • temporarily reduces fever
• do not take more than directed (see overdose warning) Adults and children 12 years and over • take two tablets fully dissolved in 8 oz of water every 4 to 6 hours as needed. • do not take more than 8 tablets in 24 hours. • do not use more than 10 days unless directed by a doctor. Children under 12 years do not use this adult product; this will provide more than the dose (overdose) of pain reliever and may cause ...
Acetaminophen 500 mg
Pain reliever/ Fever Reducer
temporarily relieves minor aches and pains due to:
▪ headache
▪ backache
▪ toothache
▪ the common cold
▪ minor pain of arthritis
▪ muscular aches
▪ premenstrual and menstrual cramps
• temporarily reduces fever
Alcohol warning: if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/ fever reducers.
Acetaminophen may cause liver damage.
Do not use with any other product containing acetaminophen
Ask a doctor before use if you have
• a sodium-restricted diet
• any liver, kidney, or heart disease
• high blood pressure
Ask a doctor or pharmacist before use if you are
• allergic or sensitive to any tablet ingredients
• pregnant, breastfeeding or may become pregnant
When using this product
• do not exceed the recommend dosage
Stop use and ask a doctor if
• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days.
If pregnant, may become pregnant, or breastfeeding, ask a health professional before use.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
• do not take more than directed (see overdose warning)
Adults and children 12 years and over
• take two tablets fully dissolved in 8 oz of water every 4 to 6 hours as needed.
• do not take more than 8 tablets in 24 hours.
• do not use more than 10 days unless directed by a doctor.
Children under 12 years do not use this adult product; this will provide more than the dose (overdose) of pain reliever and may cause liver damage.
Each tablet contains:
Sodium 192 mg.
Store at room temperature 68 F-77 F (20oC-25oC).
anhydrous citric acid, dimethicone, docusate sodium, flavors, ginger oil, lemongrass oil, mannitol, polyethylene glycol 6000, povidone K30, silicon dioxide, sodium bicarbonate, sodium carbonate, sodium chloride, sodium citrate, sucralose, sucrose.
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 13411-854-16 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-c8d1-a426-e053-dadaa90af4c2 | AcetaMax |
| 13411-854-20 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-c8d1-a426-e053-dadaa90af4c2 | AcetaMax |
| 13411-854-24 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-c8d1-a426-e053-dadaa90af4c2 | AcetaMax |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 13411-854-16 | AcetaMax | 1 in 1 BLISTER PACK | TABLET, EFFERVESCENT | 1 | 1 | |
| 13411-854-16 | AcetaMax | 16 in 1 BOX | TABLET, EFFERVESCENT | 16 | 1 | |
| 13411-854-20 | AcetaMax | 1 in 1 BLISTER PACK | TABLET, EFFERVESCENT | 1 | 1 | |
| 13411-854-20 | AcetaMax | 20 in 1 BOX | TABLET, EFFERVESCENT | 20 | 1 | |
| 13411-854-24 | AcetaMax | 1 in 1 BLISTER PACK | TABLET, EFFERVESCENT | 1 | 1 | |
| 13411-854-24 | AcetaMax | 24 in 1 BOX | TABLET, EFFERVESCENT | 24 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 13411-854 | ACETAMAX (ACETAMINOPHEN 500 MG) TABLET, EFFERVESCENT [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS] | 1 | Legacy NDC, 6 package rows | 20200904_ac8606d3-da20-4936-b8b2-75c418847f4f.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 13411-854 | 13411-854-16, 13411-854-20, 13411-854-24 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | IACT |
| GINGER OIL | SAS9Z1SVUK | IACT |
| WEST INDIAN LEMONGRASS OIL | 5BIA40E9ED | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| POLYETHYLENE GLYCOL 6000 | 30IQX730WE | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| SODIUM CARBONATE | 45P3261C7T | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SUCROSE | C151H8M554 | IACT |
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 |
|---|---|---|---|---|---|---|
| 711febe5-d7de-4d28-aa18-748bdd881d9f | ac8606d3-da20-4936-b8b2-75c418847f4f | 2020-08-31 | Warnings | 711febe5-d7de-4d28-aa18-748bdd881d9f ac8606d3-da20-4936-b8b2-75c418847f4f |
Adverse event summaries are temporarily unavailable. Other product information remains available.