TYLENOL EXTRA STRENGTH  CAPLET- acetaminophen tablet 
Jones Healthcare Group - Packaging Services, Inc

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Tylenol Extra Strength

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:

•  the common cold • headache • backache • minor pain of arthritis • toothache • muscular aches • premenstrual and menstual cramps • temporarily reduces lever

Warnings

This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours  Liver warning: 

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen. ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if you have

  • liver disease. 

Ask a 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 occur
  • 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 warnings:

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

 Adults and children 12 years and over:
  • take 2 capletes every 6 hours while symptoms last
  • do not take more than 6 capletes in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
 children under 12 years ask a doctor

Other information

Inactive ingredients

carnauba wax*, corn starch*, FD&C red no.40 aluminum lake, hypromellose, magnesium stearate, modified starch*,  polyethylene glycol*, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide * contains one or more of these ingredients

Questions or comments?

Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Package Labeling:

PouchLabel

TYLENOL EXTRA STRENGTH   CAPLET
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67414-449
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize18mm
FlavorImprint Code TYLENOL500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67414-449-002500 in 1 BOX01/24/2018
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:67414-449-1050 in 1 BOX01/24/2018
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:67414-449-1150 in 1 BOX01/24/2018
32 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01301/24/2018
Labeler - Jones Healthcare Group - Packaging Services, Inc (243261024)
Registrant - Jones Healthcare Group - Packaging Services, Inc (243261024)
Establishment
NameAddressID/FEIBusiness Operations
Dr. Reddy's Laboratories Louisiana, LLC830397282manufacture(67414-449)
Establishment
NameAddressID/FEIBusiness Operations
McNeil Healthcare LLC.831188763manufacture(67414-449)

Revised: 11/2023
Document Id: 0975230a-8729-cc07-e063-6294a90a3873
Set id: fba711c1-4e69-49b0-8994-97c455aebcb2
Version: 6
Effective Time: 20231106
 
Jones Healthcare Group - Packaging Services, Inc