TYLO EXTRA STRENGTH- acetaminophen tablet 
America Medic

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

DRUG FACTS

Acetaminophen


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

Oral Analgesic

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


Povidone
pregelatinized starch
stearic acid

Oral analgesic.

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.

image of carton image of carton

TYLO  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49638-002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (white film) Scoreno score
ShapeOVAL (TABLET) Size17mm
FlavorImprint Code C15
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49638-002-031 in 1 BOX
1NDC:49638-002-0260 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34305/15/2012
Labeler - America Medic (071065464)
Establishment
NameAddressID/FEIBusiness Operations
America Medic071065464relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Cispharma,Inc.833171445manufacture

Revised: 5/2012
Document Id: 91ec78d4-1907-43b7-a6d1-0d286b20a3c5
Set id: c08fdd22-2e0d-4467-bf70-54fcfef46550
Version: 4
Effective Time: 20120522
 
America Medic