AcetaMax PM

Manufacturer
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals | S.P.M CORPORATION
Effective date
2020-08-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:45

Label at a glance#

ProductAcetaMax PM
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE
Label structure8 sections

Indications and uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

  • Fever Reducer/Pain Reliever
  • Nighttime sleep aid

Uses

INDICATIONS & USAGE SECTION

  • temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.

Warnings

WARNINGS SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION


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

Other information

SPL UNCLASSIFIED SECTION


Each tablet contains:
Sodium 192 mg
Store at room temperature 68 F-77 F (20oC-25oC)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, dimethicone, flavors, mannitol, polyethylene glycol 6000, polysorbate 20, povidone K30, silicon dioxide, sodium bicarbonate, sodium carbonate, sodium citrate, sucralose

Image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2394042acetaminophen 500 MG / diphenhydrAMINE hydrochloride 25 MG Effervescent Oral TabletPSN1
2394042acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Effervescent Oral TabletSCD1
2394042APAP 500 MG / diphenhydramine hydrochloride 25 MG Effervescent Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13411-855-162022-01-28C16284748780-1d6a99b39-94ff-a426-e053-dadaa90af4c2AcetaMax PM
13411-855-202022-01-28C16284748780-1d6a99b39-94ff-a426-e053-dadaa90af4c2AcetaMax PM
13411-855-242022-01-28C16284748780-1d6a99b39-94ff-a426-e053-dadaa90af4c2AcetaMax PM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13411-855-16AcetaMax PM16 in 1 BOXTABLET, EFFERVESCENT161
13411-855-16AcetaMax PM1 in 1 BLISTER PACKTABLET, EFFERVESCENT11
13411-855-20AcetaMax PM1 in 1 BLISTER PACKTABLET, EFFERVESCENT11
13411-855-20AcetaMax PM20 in 1 BOXTABLET, EFFERVESCENT201
13411-855-24AcetaMax PM24 in 1 BOXTABLET, EFFERVESCENT241
13411-855-24AcetaMax PM1 in 1 BLISTER PACKTABLET, EFFERVESCENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13411-855ACETAMAX PM (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, EFFERVESCENT [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS]1Legacy NDC, 6 package rows20200904_843123f9-480d-4e56-b639-fd345a49c7ab.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13411-85513411-855-16, 13411-855-20, 13411-855-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7e8b1b33-14b9-4c83-ac11-21b24d78e8f5843123f9-480d-4e56-b639-fd345a49c7ab2020-08-31WarningsExact identifier
spl id: 7e8b1b33-14b9-4c83-ac11-21b24d78e8f5
spl set id: 843123f9-480d-4e56-b639-fd345a49c7ab

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.