DRUG FACTS

Manufacturer: America Medic | Cispharma,Inc.
Effective date: 2012-05-22
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:32:02

Label at a glance#

ProductTYLO Extra Strength

Active ingredientAcetaminophen

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help right away and contact a poison control center right away.

OTC - PURPOSE SECTION

Oral Analgesic

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over: Take 2 tablets at bedtime(Do not take more than 2 tablets in a 24 hour time)

INACTIVE INGREDIENT SECTION

Povidone
pregelatinized starch
stearic acid

INDICATIONS & USAGE SECTION

Oral analgesic.

WARNINGS SECTION

Do not use this product if you have had an allergic to Acetaminophen or any of the inactive ingredients. Ask a doctor before taking this product if you have Liver disease or are taking blood thinning medication. Do not take more than directed.If pregnant or breast feeding contact a doctor before using this product. Stop use and consult a doctor if: Pain gets worse or last more than 10 days: If fever gets worse or last more than 3 days: new symptoms appear: redness or swelling appear.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton image of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	4
198440	acetaminophen 500 MG Oral Tablet	SCD	4
198440	APAP 500 MG Oral Tablet	SY	4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49638-002-03	2019-11-13	C162847	48780-1	97449f38-cf1d-f6ea-e053-dbdaa90aa703	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49638-002-02	TYLOExtra Strength	60 in 1 BOTTLE	TABLET	60		4
49638-002-03	TYLOExtra Strength	1 in 1 BOX	TABLET	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49638-002	TYLO EXTRA STRENGTH (ACETAMINOPHEN) TABLET [AMERICA MEDIC]	4	Legacy NDC, 2 package rows	20120523_c08fdd22-2e0d-4467-bf70-54fcfef46550.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	4
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	4

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

TYLO Extra Strength
Acetaminophen
POVIDONE
STARCH, CORN
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49638-002	49638-002-02, 49638-002-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Acetaminophen	362O9ITL9D	ACTIB
POVIDONE	FZ989GH94E	IACT
STARCH, CORN	O8232NY3SJ	IACT
STEARIC ACID	4ELV7Z65AP	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 78 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / VAGINAL	4 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	PASTILLE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE, EXTENDED RELEASE / ORAL		56 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / BUCCAL	16.6 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / VAGINAL		1088 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	DROPS / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FOR SUSPENSION / ORAL	2 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, DELAYED RELEASE / ORAL		713 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL		216 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION, EXTENDED RELEASE / ORAL		113 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TROCHE / ORAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	PELLET / SUBCUTANEOUS	0.97 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, ORALLY DISINTEGRATING / ORAL	15.03 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING / ORAL		100 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	IMPLANT / SUBCUTANEOUS	6 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SOLUTION / ORAL		3000 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SUSPENSION / OPHTHALMIC	1.8 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOAP / TOPICAL	6 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, DELAYED RELEASE / ORAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION / ORAL		900 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / BUCCAL	6 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / SUBLINGUAL		409 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / SUBLINGUAL	9 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		350 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	OINTMENT / TOPICAL	15 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SOLUTION / OPHTHALMIC	1.8 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	DROPS / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / TOPICAL	8 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	INSERT / VAGINAL		147 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, EXTENDED RELEASE / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE, COATED PELLETS / ORAL	10.03 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		21 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	POWDER, FOR SUSPENSION / ORAL		34 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SYSTEM / TOPICAL		41 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
91ec78d4-1907-43b7-a6d1-0d286b20a3c5			c08fdd22-2e0d-4467-bf70-54fcfef46550	2012-05-22	Warnings	Exact identifier spl id: 91ec78d4-1907-43b7-a6d1-0d286b20a3c5 spl set id: c08fdd22-2e0d-4467-bf70-54fcfef46550

Reported adverse events (FAERS/openFDA)#

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