AcetaMax

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 23:26:47

Label at a glance#

ProductAcetaMax
Active ingredientACETAMINOPHEN
Label structure9 sections

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

Dosage and administration

• 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 ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/ Fever Reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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.

KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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.

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, 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.

Image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1536880acetaminophen 500 MG Effervescent Oral TabletPSN1
1536880acetaminophen 500 MG Effervescent Oral TabletSCD1
1536880APAP 500 MG Effervescent Oral TabletSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13411-854-162022-01-28C16284748780-1d6a99b39-c8d1-a426-e053-dadaa90af4c2AcetaMax
13411-854-202022-01-28C16284748780-1d6a99b39-c8d1-a426-e053-dadaa90af4c2AcetaMax
13411-854-242022-01-28C16284748780-1d6a99b39-c8d1-a426-e053-dadaa90af4c2AcetaMax

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13411-854-16AcetaMax1 in 1 BLISTER PACKTABLET, EFFERVESCENT11
13411-854-16AcetaMax16 in 1 BOXTABLET, EFFERVESCENT161
13411-854-20AcetaMax1 in 1 BLISTER PACKTABLET, EFFERVESCENT11
13411-854-20AcetaMax20 in 1 BOXTABLET, EFFERVESCENT201
13411-854-24AcetaMax1 in 1 BLISTER PACKTABLET, EFFERVESCENT11
13411-854-24AcetaMax24 in 1 BOXTABLET, EFFERVESCENT241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13411-854ACETAMAX (ACETAMINOPHEN 500 MG) TABLET, EFFERVESCENT [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS]1Legacy NDC, 6 package rows20200904_ac8606d3-da20-4936-b8b2-75c418847f4f.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13411-85413411-854-16, 13411-854-20, 13411-854-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
711febe5-d7de-4d28-aa18-748bdd881d9fac8606d3-da20-4936-b8b2-75c418847f4f2020-08-31WarningsExact identifier
spl id: 711febe5-d7de-4d28-aa18-748bdd881d9f
spl set id: ac8606d3-da20-4936-b8b2-75c418847f4f

Reported adverse events (FAERS/openFDA)#

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