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Tylo Extra

Medically reviewed by Drugs.com. Last updated on Jan 12, 2021.

Dosage form: tablet, delayed release
Ingredients: ACETAMINOPHEN 500mg
Labeler: America Medic & Science, LLC
NDC Code: 49638-110

Tylo Extra 500 mg

Tylo Extra 500 mg

Drug Facts

Active Ingredient

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
  • headache
  • backache
  • minor pain of arthritis
  • temporarily reduces fever
  • the common cold
  • toothache
  • menstrual cramps
  • muscular aches

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product.

Do not use
  • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you have ever had an allergic reaction to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if you have liver disease

Ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms appear
  • redness or swelling is present

These could be signs of a serious condition

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed (see overdose warning).

Adults and children 12 years and over:

  • take 2 caplets every 4 to 6 hours
  • Do not take more than 8 caplets of this product in 24 hours.

Children under 12 years:

  • do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information
  • store at 25°C (77°F)
  • see end panel for lot number and expiration date

Inactive ingredients
  • Carnauba wax, hypromellose, polyethylene glycol, propylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

call toll free 1-855-470-6722

Tylo Extra 500 mg

TYLO EXTRA 
acetaminophen tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49638-110
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
HYPROMELLOSE, UNSPECIFIED 
POLYETHYLENE GLYCOL, UNSPECIFIED 
PROPYLENE GLYCOL 
POVIDONE 
STARCH, CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapecapsuleSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49638-110-301 BOTTLE in 1 CARTON
130 TABLET, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/17/2019
Labeler - America Medic & Science, LLC (071065464)
Registrant - America Medic & Science, LLC (071065464)
Establishment
NameAddressID/FEIOperations
Time Cap Laboratories, Inc037052099manufacture(49638-110)

 
America Medic & Science, LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.