TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated

Tylenol Extra Strength by

Drug Labeling and Warnings

Tylenol Extra Strength by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (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 menstrual cramps
 temporarily reduces fevers

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 warning: 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 6 hours while symptoms last

  do not take more than 6 caplets 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 20-25°C (68-77°F)

see bottom of carton for lot number and expiration date
do not use if pouch is opened

Inactive ingredients

carnauba wax*, corn starch, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, 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 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-167(NDC:50580-449)
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)
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	19mm
Flavor		Imprint Code	TYLENOL;500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-167-01	1 in 1 CARTON	09/22/2016
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 67751-167-02	1 in 1 CARTON	09/22/2016
2		4 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 67751-167-04	12 in 1 TRAY	09/22/2016
3		1 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	09/22/2016

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-167) , repack(67751-167)