NDC 49638-110

Tylo Extra

Acetaminophen

Tylo Extra is a Oral Tablet, Delayed Release in the Human Otc Drug category. It is labeled and distributed by America Medic & Science, Llc. The primary component is Acetaminophen.

Product ID49638-110_03335fc0-f330-4f92-aabb-1757a4b8ab41
NDC49638-110
Product TypeHuman Otc Drug
Proprietary NameTylo Extra
Generic NameAcetaminophen
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-01-17
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameAmerica Medic & Science, LLC
Substance NameACETAMINOPHEN
Active Ingredient Strength500 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 49638-110-30

1 BOTTLE in 1 CARTON (49638-110-30) > 30 TABLET, DELAYED RELEASE in 1 BOTTLE
Marketing Start Date2019-01-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49638-110-30 [49638011030]

Tylo Extra TABLET, DELAYED RELEASE
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-17

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN500 mg/1

OpenFDA Data

SPL SET ID:dac7c13d-c021-4a6e-9b14-0e312dd0ea2f
Manufacturer
UNII

NDC Crossover Matching brand name "Tylo Extra" or generic name "Acetaminophen"

NDCBrand NameGeneric Name
49638-110Tylo ExtraTylo Extra
0121-0657AcetaminophenAcetaminophen
0113-7000Basic Care acetaminophenAcetaminophen
0113-7484basic care acetaminophenAcetaminophen
0113-7544Basic Care AcetaminophenAcetaminophen
0113-7130basic care childrens pain and feverAcetaminophen
0113-0020good sense childrens pain and feverAcetaminophen
0113-0212Good Sense Childrens Pain and FeverAcetaminophen
0113-0608good sense childrens pain and feverAcetaminophen
0113-0998Good Sense Childrens Pain and FeverAcetaminophen
0113-0161Good Sense pain and feverAcetaminophen
0113-0397Good Sense Pain and Feveracetaminophen
0113-0590Good Sense Pain and Feveracetaminophen
0113-0946good sense pain and feverAcetaminophen
0113-8959Good Sense Pain and FeverAcetaminophen
0113-0025Good Sense Pain ReliefAcetaminophen
0113-0044Good Sense Pain ReliefAcetaminophen
0113-0187good sense pain reliefAcetaminophen
0113-0217good sense pain reliefAcetaminophen
0113-0227Good Sense Pain ReliefAcetaminophen
0113-0403good sense pain reliefAcetaminophen
0113-0484Good Sense Pain ReliefAcetaminophen
0113-0518good sense pain reliefAcetaminophen
0113-0544good sense pain reliefAcetaminophen
0113-1889good sense pain reliefacetaminophen
0113-1975Good Sense Pain ReliefAcetaminophen
0031-9301Robitussin Direct Sore Throat Painacetaminophen

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.