TYLO EXTRA STRENGTH- acetaminophen tablet

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Acetaminophen

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

Oral Analgesic

DOSAGE & ADMINISTRATION

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

Povidone
pregelatinized starch
stearic acid

INDICATIONS & USAGE

Oral analgesic.

WARNINGS

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.

PRINCIPAL DISPLAY PANEL

image of carton

INGREDIENTS AND APPEARANCE

TYLO  EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49638-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	500 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (white film)	Score	no score
Shape	OVAL (TABLET)	Size	17mm
Flavor		Imprint Code	C15
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49638-002-03	1 in 1 BOX
1	NDC: 49638-002-02	60 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	05/15/2012

Labeler - America Medic (071065464)

Establishment
Name	Address	ID/FEI	Business Operations
America Medic		071065464	relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Cispharma,Inc.		833171445	manufacture