TYLENOL EXTRA STRENGTH CAPLET- acetaminophen tablet

Tylenol Extra Strength by

Drug Labeling and Warnings

Tylenol Extra Strength by is a Otc medication manufactured, distributed, or labeled by Jones Healthcare Group - Packaging Services, Inc, Dr. Reddy's Laboratories Louisiana, LLC, McNeil Healthcare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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. Allergy alert: acetaminophen may cause severe skin reactions.symptoms may include:
• skin reddening
• blisters
• rash if a skin reaction occurs. stop use and seek medical help right away. 

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

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

• 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

• store between 20-25C (68-77F) 
• do not use if pouch is torn or damaged. 

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:

INGREDIENTS AND APPEARANCE

TYLENOL EXTRA STRENGTH  CAPLET
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67414-449
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	TYLENOL500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67414-449-00	2500 in 1 BOX	01/24/2018
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 67414-449-10	50 in 1 BOX	01/24/2018
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 67414-449-11	50 in 1 BOX	01/24/2018
3		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/24/2018

Labeler - Jones Contract Packaging Services (243697187)

Registrant - Jones Contract Packaging Services (243697187)

Establishment
Name	Address	ID/FEI	Business Operations
Jones Contract Packaging Services		243697187	pack(67414-449)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. Reddy's Laboratories Louisiana, LLC		830397282	manufacture(67414-449)

Establishment
Name	Address	ID/FEI	Business Operations
McNeil Healthcare LLC.		831188763	manufacture(67414-449)