Tylenol® Regular Strength

Drug Labeling and Warnings

Drug Details [pdf]

TYLENOL  REGULAR STRENGTH- acetaminophen tablet, film coated 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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.

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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

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
  • do not use for more than 10 days unless directed by a doctor
• children 6 - 11 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 years: ask a doctor

Other information

• store between 20-25°C (68-77°F)
• do not use if carton is opened or neck wrap or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing

Inactive ingredients

carnauba wax, castor oil1, corn starch, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

1 may contain castor oil

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC: 50580-501-50
325mg

TYLENOL®

Acetaminophen Pain Reliever - Fever Reducer

Regular Strength

FOR HOSPITAL AND GOVERNMENT USE ONLY

50 Caplets
325 mg each

TYLENOL   REGULAR STRENGTH
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-501
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg

Inactive Ingredients
Ingredient Name	Strength
carnauba wax (UNII: R12CBM0EIZ)
castor oil (UNII: D5340Y2I9G)
starch, corn (UNII: O8232NY3SJ)
FD&C red no. 40 (UNII: WZB9127XOA)
aluminum oxide (UNII: LMI26O6933)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
magnesium stearate (UNII: 70097M6I30)
powdered cellulose (UNII: SMD1X3XO9M)
propylene glycol (UNII: 6DC9Q167V3)
shellac (UNII: 46N107B71O)
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	TYLENOL;325;HOSPITAL
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-501-10	10 in 1 CARTON	02/01/1999	06/30/2019
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 50580-501-30	150 in 1 BOX	02/01/1999	11/30/2016
2		1 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 50580-501-50	1 in 1 CARTON	02/01/1999	05/31/2019
3		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 50580-501-80	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/1999	05/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	02/01/1999	06/30/2019

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 7/2019

Document Id: 350b41df-6662-4062-bd92-8b41e53e64fe

34390-5

Set id: 01f424ab-adf2-413e-be8f-b2d0a83a55a3

Version: 8

Effective Time: 20190712

 

Johnson & Johnson Consumer I