Indications and uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
Do not take more than directed (see overdose warning) Adults and children 12 years and over: • take 2 tablets fully dissolved in 8oz of water at bedtime. • do not take more than 2 tablets of this product in 24 hours Children under 12 years: do not use
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
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.
• with any other product containing diphenhydramine, even one used on skin
• in children under 12 years of age
• if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
• a sodium-restricted diet.
• liver disease
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland
• glaucoma
Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers
When using this product
• drowsiness will occur
• avoid alcoholic drinks
• do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• These could be signs 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. 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 2 tablets fully dissolved in 8oz of water at bedtime.
• do not take more than 2 tablets of this product in 24 hours
Children under 12 years: do not use
Each tablet contains:
Sodium 192 mg
Store at room temperature 68 F-77 F (20oC-25oC)
anhydrous citric acid, dimethicone, flavors, mannitol, polyethylene glycol 6000, polysorbate 20, povidone K30, silicon dioxide, sodium bicarbonate, sodium carbonate, sodium citrate, sucralose
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2394042 | acetaminophen 500 MG / diphenhydrAMINE hydrochloride 25 MG Effervescent Oral Tablet | PSN | 1 |
| 2394042 | acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Effervescent Oral Tablet | SCD | 1 |
| 2394042 | APAP 500 MG / diphenhydramine hydrochloride 25 MG Effervescent Oral Tablet | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 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 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 13411-855-16 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-94ff-a426-e053-dadaa90af4c2 | AcetaMax PM |
| 13411-855-20 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-94ff-a426-e053-dadaa90af4c2 | AcetaMax PM |
| 13411-855-24 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-94ff-a426-e053-dadaa90af4c2 | AcetaMax PM |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 13411-855-16 | AcetaMax PM | 16 in 1 BOX | TABLET, EFFERVESCENT | 16 | 1 | |
| 13411-855-16 | AcetaMax PM | 1 in 1 BLISTER PACK | TABLET, EFFERVESCENT | 1 | 1 | |
| 13411-855-20 | AcetaMax PM | 1 in 1 BLISTER PACK | TABLET, EFFERVESCENT | 1 | 1 | |
| 13411-855-20 | AcetaMax PM | 20 in 1 BOX | TABLET, EFFERVESCENT | 20 | 1 | |
| 13411-855-24 | AcetaMax PM | 24 in 1 BOX | TABLET, EFFERVESCENT | 24 | 1 | |
| 13411-855-24 | AcetaMax PM | 1 in 1 BLISTER PACK | TABLET, EFFERVESCENT | 1 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 13411-855 | ACETAMAX PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, EFFERVESCENT [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS] | 1 | Legacy NDC, 6 package rows | 20200904_843123f9-480d-4e56-b639-fd345a49c7ab.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 13411-855 | 13411-855-16, 13411-855-20, 13411-855-24 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DIPHENHYDRAMINE | 8GTS82S83M | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| POLYETHYLENE GLYCOL 6000 | 30IQX730WE | IACT |
| POLYSORBATE 20 | 7T1F30V5YH | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| SODIUM CARBONATE | 45P3261C7T | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | 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 |
|---|---|---|---|---|---|---|
| 7e8b1b33-14b9-4c83-ac11-21b24d78e8f5 | 843123f9-480d-4e56-b639-fd345a49c7ab | 2020-08-31 | Warnings | 7e8b1b33-14b9-4c83-ac11-21b24d78e8f5 843123f9-480d-4e56-b639-fd345a49c7ab |
Adverse event summaries are temporarily unavailable. Other product information remains available.