FDA.reportPublic FDA data

Acetaminophen Extra Strength Caplets

Manufacturer
Genexa Inc.
Effective date
2026-05-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:57:04

Label at a glance#

ProductGenexa Acetaminophen Extra Strength
Active ingredientACETAMINOPHEN
Label structure12 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Acetaminophen 500 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
  • temporarily reduces fever

WARNINGS SECTION

Warnings

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.

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 you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

• do not take more than directed (see Overdose warning)

adults and children 12 years and over
  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days, unless directed by a doctor
children under 12 yearsask a doctor

OTHER SAFETY INFORMATION

Other information

  • each caplet contains: calcium 12 mg
  • store between 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

acacia gum ‡, agave fiber ‡, agave syrup ‡, calcium carbonate ‡, carnauba wax (organic), cellulose ‡, dextrose ‡, dibehenin (vegetable source) ‡, glycerin ‡, guar gum ‡, maltodextrin ‡, rice extract ‡, rice hulls ‡, sodium bicarbonate ‡, sunflower lecithin (organic), sunflower oil ‡

‡natural

OTC - QUESTIONS SECTION

Questions? 1-855-436-3921

SPL UNCLASSIFIED SECTION

DO NOT use if seal on top and bottom of carton or under cap of bottle is disturbed or missing.

Made in the USA with globally sourced ingredients

Distributed by: Genexa Inc., Atlanta, GA 30324

genexa.com

RECENT MAJOR CHANGES SECTION

Directions

  • do not take more than directed (see Overdose warning)
adults and children 12 years and over
  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days, unless directed by a doctor
children under 12 yearsask a doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Genexa ®

CLEAN MEDICINE

EXTRA STRENGTH

Acetaminophen

Pain Reliever / Fever Reducer

500 mg per Caplet

0% Artificial Additives, Dyes, Common Allergens, Artificial Sweeteners

10002-GNX carton_R-2026012310002-GNX carton_R-20260123

10030-GNX carton_R-2026012310030-GNX carton_R-20260123

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN7
198440acetaminophen 500 MG Oral TabletSCD7
198440APAP 500 MG Oral TabletSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69676-0059-22025-02-26C16284748780-12cef2736-92bf-d83d-e063-dadaa90ab31fAcetaminophen Extra Strength Caplets
69676-0059-52025-02-26C16284748780-12cef2736-92bf-d83d-e063-dadaa90ab31fAcetaminophen Extra Strength Caplets
69676-0059-22025-01-30C16284748780-12cef2736-92bf-d83d-e063-dadaa90ab31fAcetaminophen Extra Strength Caplets
69676-0059-52025-01-30C16284748780-12cef2736-92bf-d83d-e063-dadaa90ab31fAcetaminophen Extra Strength Caplets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0059-2Genexa AcetaminophenExtra Strength100 in 1 BOTTLETABLET, COATED1007
69676-0059-2Genexa AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED17
69676-0059-5Genexa AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED17
69676-0059-5Genexa AcetaminophenExtra Strength50 in 1 BOTTLETABLET, COATED507

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-005969676-0059-2, 69676-0059-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACACIA5C5403N26OIACT
INULINJOS53KRJ01IACT
GUAR GUME89I1637KEIACT
AGAVE TEQUILANA JUICEGVG8G0207OIACT
CARNAUBA WAXR12CBM0EIZIACT
DEXTROSEIY9XDZ35W2IACT
ACETAMINOPHEN362O9ITL9DACTIB
MALTODEXTRIN7CVR7L4A2DIACT
SODIUM BICARBONATE8MDF5V39QOIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
CALCIUM CARBONATEH0G9379FGKIACT
RICE BRANR60QEP13ICIACT
GLYCERYL DIBEHENATER8WTH25YS2IACT
SUNFLOWER OIL3W1JG795YIIACT
POWDERED CELLULOSESMD1X3XO9MIACT
GLYCERINPDC6A3C0OXIACT

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
Genexa Acetaminophen Extra StrengthACETAMINOPHENGenexa Inc.d6f968ca-719f-5a68-e053-2995a90a4afa2026-05-08WarningsExact identifier
ndc (package): 69676-0059-5
ndc (package): 69676-0059-2
ndc (product): 69676-0059
ndc11 (package): 69676005905
ndc11 (package): 69676005902
spl id: 51590662-8dac-1b90-e063-6294a90a49a2
spl set id: d6f968ca-719f-5a68-e053-2995a90a4afa

Reported adverse events (FAERS/openFDA)#

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