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TYLENOL Regular Strength by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Medically reviewed on November 8, 2017

Dosage form: tablet, film coated
Ingredients: Acetaminophen 325mg
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-600

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
Regular Strength

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

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

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours for adults or 5 caplets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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 the user has liver disease

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Stop use and ask a doctor if
  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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 4 to 6 hours while symptoms last
  • do not take more than 10 caplets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years
  • take 1 caplet every 4 to 6 hours while symptoms last
  • do not take more than 5 caplets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
children under 6 yearsask a doctor

Other information
  • store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
  • do not use if any individual blister unit is open or torn

Inactive ingredients

carnauba wax, crospovidone, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

325mg

NDC 50580-600-02
To re-order reference the NDC code

TYLENOL®
Acetaminophen
Pain Reliever - Fever Reducer
Regular Strength

EZ DOSE

100 Caplets
325 mg each

10 Blister Cards
with
10 Individual Blisters

SMART PACKAGING
DESIGNED FOR HEALTH
CARE PROFESSIONALS

FOR HOSPITAL AND GOVERNMENT USE ONLY

TYLENOL   REGULAR STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-600
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Inactive Ingredients
Ingredient NameStrength
carnauba wax 
crospovidone, unspecified 
FD&C red no. 40 
aluminum oxide 
hypromellose, unspecified 
magnesium stearate 
medium-chain triglycerides 
microcrystalline cellulose 
povidone, unspecified 
propylene glycol 
sodium starch glycolate type A potato 
stearic acid 
titanium dioxide 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorImprint CodeTYLENOL;325;HOSPITAL
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-600-0150 TABLET, FILM COATED in 1 BOTTLE
2NDC:50580-600-0210 BLISTER PACK in 1 CARTON
210 TABLET, FILM COATED in 1 BLISTER PACK
3NDC:50580-600-031000 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/31/2017
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

← See all TYLENOL Regular 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.

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