Excinol Arthritis (Acetaminophen)

Manufacturer
America Medic & Science, LLC | Time Cap Laboratories, Inc
Effective date
2019-01-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:19

Label at a glance#

ProductExcinol Arthritis (Acetaminophen)
Active ingredientACETAMINOPHEN
Label structure17 sections

Indications and uses

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

Dosage and administration

do not take more than directed (see overdose warning). take 2 caplets every 8 hours with water. Swallow whole—do not crush, chew, split or dissolve. Do not take more than 6 caplets in 24 hours. Do not use for more than 10 days unless directed by a doctor. Children Under 18 years of age ask a doctor.

Label contents#

Full prescribing information#

Excinol Arthritis (Acetaminophen) 650 mg

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

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.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you have ever had an allergic reaction 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 your 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 appear
  • 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.

Overdose warning

SPL UNCLASSIFIED 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 right away. (1-800-222-1222) 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).

  • take 2 caplets every 8 hours with water.
  • Swallow whole—do not crush, chew, split or dissolve.
  • Do not take more than 6 caplets in 24 hours.
  • Do not use for more than 10 days unless directed by a doctor.

Children

  • Under 18 years of age ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • store between 20-25°C (68-77°F)
  • do not use if neck wrap is broken or missing
  • see end panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

  • carnauba wax, corn starch, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-855-470-6722

Excinol Arthritis (Acetaminophen) 650 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49638-103-302023-01-30C16284748780-1f386c649-a2bd-0266-e053-dadaa90a7c1aExcinol Arthritis (Acetaminophen) 650 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49638-103-30Excinol Arthritis (Acetaminophen)30 in 1 BOTTLETABLET, DELAYED RELEASE301
49638-103-30Excinol Arthritis (Acetaminophen)1 in 1 CARTONTABLET, DELAYED RELEASE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49638-103EXCINOL ARTHRITIS (ACETAMINOPHEN) (ACETAMINOPHEN) TABLET, DELAYED RELEASE [AMERICA MEDIC & SCIENCE, LLC]1Legacy NDC, 2 package rows20190124_cf25c8c1-057b-43e0-a040-b6361977ee24.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49638-10349638-103-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
dd8667e5-1210-47c4-8f64-7303930f3340cf25c8c1-057b-43e0-a040-b6361977ee242019-01-22WarningsExact identifier
spl id: dd8667e5-1210-47c4-8f64-7303930f3340
spl set id: cf25c8c1-057b-43e0-a040-b6361977ee24

Reported adverse events (FAERS/openFDA)#

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