FDA.reportPublic FDA data

Acetaminophen Extra Strength

Manufacturer
Aldama Pharmaceuticals, Inc
Effective date
2026-05-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-06-03 18:04:09

Label at a glance#

ProductAcetaminophen Extra Strength
Active ingredientACETAMINOPHEN
Label structure16 sections

Indications and uses

Temporarily relieves minor aches and pains temporarily reduces fever

Label contents#

Full prescribing information#

Active ingredient (in each 15 mL-teaspoonful)

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
    • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoonfuls in 24 hours. Severe liver damage may occur if:you take

  • more than 8 tablespoonfuls (4,000mg of acetaminophen) in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using the 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.

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your childhas liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use if you have taking the blood thinning drug warfarin.

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose

OTC - STOP USE SECTION

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 signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or conbtact a Poison Control Center right away.  Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than directed
AgeDOSE
Adults and children 12 years of age and olderTake 1 to 2 tablespoonfuls every 4 to 6 hours as needed, not more than 6 Tablespoonfuls in 24 hours
Children under 12 yearsDo not use

OTHER SAFETY INFORMATION

Other information

  • store at room temperature between 15-30°C (59-86°F)
  • protect from freezing
  • protect from light
  • TAMPER EVIDENT do not use if foil seal over bottle opening is torn, broken or missing

INACTIVE INGREDIENT SECTION

Inactive Ingredient

artificial and natural cherry flavor, citric acid, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

OTC - QUESTIONS SECTION

Question or Comments?

call 305-592-9216 or info@aldamapharm.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307684acetaminophen 500 MG in 15 mL Oral SolutionPSN2
307684acetaminophen 33.3 MG/ML Oral SolutionSCD2
307684APAP 1000 MG per 30 ML Oral SolutionSY2
307684APAP 167 MG per 5 ML Oral SolutionSY2
307684APAP 33.3 MG/ML Oral SolutionSY2
307684APAP 500 MG per 15 ML Oral SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73564-81773564-817-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POLYETHYLENE GLYCOL 350ZBR3T82M2VIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM CITRATE1Q73Q2JULRIACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-01-20full-release2026-06-01 01:34:11

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
58b7b174-dc7c-aac2-e063-6294a90acfea48dc8d92-16ee-b359-e063-6294a90a26af2026-08-10WarningsExact identifier
spl set id: 48dc8d92-16ee-b359-e063-6294a90a26af

Reported adverse events (FAERS/openFDA)#

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