FDA.reportPublic FDA data

Tylo Arthritis (Acetaminophen)

Manufacturer
America Medic & Science, LLC | Elvi Pharma LLC.
Effective date
2021-07-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:40:42

Label at a glance#

ProductTylo 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#

Tylo 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 or any other blood thinner.

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

  • Povidone, Pregelatinized Starch, Crosspovidone, Stearic Acid, Titanium Dioxide, Carnauba Wax, Hypromellose, Polyethylene Glycol.

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-855-470-6722

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Updated carton displayUpdated carton displaydrug factsdrug factsdrug facts contdrug facts contUpdated DF Cont 2Updated DF Cont 2bottlebottle

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49638-104-302023-07-28C16284748780-10191ceaa-642e-198a-e063-dbdaa90aec3eTylo Arthritis (Acetaminophen) 650 mg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49638-104TYLO ARTHRITIS (ACETAMINOPHEN) (ACETAMINOPHEN) TABLET, DELAYED RELEASE [AMERICA MEDIC & SCIENCE, LLC]5Legacy NDC20210715_8f3c3cea-a72f-48c5-817d-aea8745efe67.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49638-10449638-104-30

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
CROSPOVIDONE2S7830E561IACT
CARNAUBA WAXR12CBM0EIZIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POVIDONEFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
STEARIC ACID4ELV7Z65APIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT

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
c71bfbf5-6009-13b2-e053-2a95a90aac018f3c3cea-a72f-48c5-817d-aea8745efe672021-07-14WarningsExact identifier
spl id: c71bfbf5-6009-13b2-e053-2a95a90aac01
spl set id: 8f3c3cea-a72f-48c5-817d-aea8745efe67

Reported adverse events (FAERS/openFDA)#

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