Skip to Content

← See all Tylenol Extra Strength brands

Tylenol Extra Strength by Navajo Manufacturing Company Inc.

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Navajo Manufacturing Company Inc.
NDC Code: 67751-167

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.

Tylenol Extra Strength

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:

TYLENOL EXTRA STRENGTH 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-167(NDC:50580-449)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
STARCH, CORN 
FD&C RED NO. 40 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POWDERED CELLULOSE 
PROPYLENE GLYCOL 
SHELLAC 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize18mm
FlavorImprint CodeTYLENOL;500
Contains    
Packaging
#Item CodePackage Description
1NDC:67751-167-011 POUCH in 1 CARTON
12 TABLET in 1 POUCH
2NDC:67751-167-021 POUCH in 1 CARTON
24 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/22/2016
Labeler - Navajo Manufacturing Company Inc. (091917799)

Revised: 09/2016
 
Navajo Manufacturing Company Inc.

← See all Tylenol Extra Strength brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide