OTC Medication Information: TYLO Extra Strength

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.

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.

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TYLO EXTRA STRENGTH
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49638-002
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 500 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color white (white film) Score no score
Shape OVAL (TABLET) Size 17mm
Flavor Imprint Code C15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49638-002-03 1 BOTTLE (BOTTLE) in 1 BOX contains a BOTTLE (49638-002-02)
1 NDC:49638-002-02 60 TABLET (TABLET) in 1 BOTTLE This package is contained within the BOX (49638-002-03)
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 Operations
America Medic 071065464 relabel, repack
Establishment
Name Address ID/FEI Operations
Cispharma,Inc. 833171445 manufacture

Revised: 05/2012 America Medic

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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