TYLENOL® Extra Strength Caplets2

Doc ID: J0105229 Version:2.
0 Status:Approved
TYLENOL® Extra Strength Caplets

NDC Family Code: 449
Formula #: C-85-31, C-85-64, C-85-65
NDC #: 50580-449-XX
NDA #/monograph citation (final or tentative): 21 CFR 343 (tentative)
Note: Information in this section is for Drug Listing purposes
Proprietary Name: TYLENOL® Extra Strength
Proprietary Name Suffix: N/A
Dosage Form: Tablet, film coated
Use if applicable – do not type instructions that are shaded.

Important: Read all product information before using. Keep xxx (i.e., this, the – do not
type instructions that are shaded) box for important information.
Drug Facts
Active ingredient (in each caplet) Purpose
Acetaminophen 500 mg .........................................................................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 fever
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
Page 1 of 7
COMPANY CONFIDENTIAL
Doc ID: J0105229 Version:2.0 Status:Approved

Formula #: C-85-31, C-85-64, C-85-65
NDC #: 50580-449-XX
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 ■ take 2 caplets every 6 hours while symptoms
over 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)
■ tamper evident statement (varies by packaging configuration) (insert if appropriate - do
not type instructions that are shaded)
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)
Page 2 of 7

Formula #: C-85-31, C-85-64, C-85-65
NDC #: 50580-449-XX
Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
McNeil Consumer Healthcare Division
Fort Washington, PA 19034 USA
©J&JCI 20XX (insert current year - do not type instructions that are shaded)
Page 3 of 7

Formula #: C-85-31, C-85-64, C-85-65
NDC #: 50580-449-XX
Revision History:
 07/20/2015: updated company signature line
 09/03/2014: New Labeling Information Sheet in CONNECT for Product Family Code 449.
Change from drug facts content from EDM version 18.0: Added “modified starch*” to the
inactive ingredients per MFR-C-85-31 Version 2.0 and MFR-C-85-64 Version 1.0. Added an
asterisk after “corn starch”. Removed alcohol content information and cation information.
 09/30/2013: Removed “CONTAINS ACETAMINOPHEN…” statement prior to Drug

Facts.
 09/27/2013: Under Warnings, added allergy alert warning per FDA correspondence dated
8/1/13 to NDA 19-872. Removed castor oil from list of inactive ingredients. Remove “451”,
“(Retail)”, and “50580-451-XX (Hospital/Government)” from header. Family code 451 is
now covered under LIS-451. Added Formula # C-86-65 and removed Formula # C-85-63.
Updated cation information for Magnesium and Sodium from 1 mg per caplet to 0 mg per
caplet.
 04/03/2013: Added “CONTAINS ACETAMINOPHEN…” statement prior to Drug Facts
 07/27/2012: Revised Liver warning to remove “The maximum daily dose…” sentence.
 05/07/2012: Updated header to reflect new standard information and format. Under
Overdose warning, removed the sentence “Taking more than the recommended dose
(overdose) may cause liver damage.” per FDA correspondence dated 12/23/11 for NDA 19-
872/S-036. Added instructional text “(varies by packaging configuration) (insert if
appropriate- do not type instructions that are shaded)” after tamper evident statement.
Removed lot number and expiration date statement. In Inactive Ingredients, changed “#” to
“no.” per revised MFR. Updated Questions or Comments to read “call 1-877-895-3665
(toll-free) or 215-273-8755 (collect).” Revised case of company signature line to read
“McNeil Consumer Healthcare”, “Division of McNEIL-PPC, Inc.”, “Fort Washington, PA
19034 USA”. Revised copyright language to read “©McNEIL-PPC, INC. XXXX or
Page 4 of 7

Formula #: C-85-31, C-85-64, C-85-65
NDC #: 50580-449-XX
©MCN-PPC, INC. XXXX as space allows. (insert current year – do not type instructions
that are shaded).” Added chart for alcohol and cation information.
 4/1/2011: Reformatted sub-bullets in Uses section; Update Directions, to replace “do not use
this adult product….liver damage” with “ask a doctor”
 1/21/2011: Updated product name in header to “Caplets” and remove reference of “(Las
Piedras) (BASF) formulations”. Updated Directions section to remove 2nd bullet prior to
dosing chart; updated first bullet in adults and children 12 years and older section to read
“take 2 caplets every 6 hours while symptoms last”, and removed the 2nd and 3rd bullet within
the same section.
 08/06/2010: Updated to rearrange margins
 08/03/2010: Updated Liver warning to add the statement, “The maximum daily dose of this
product is 6 caplets (3,000 mg) in 24 hours.”
 03/04/2010: Updated per McNeil Risk Management Plan as presented to FDA.  Updated
Warnings section and Directions section.
 07/06/2009: Added “Important…” statement prior to Drug Facts; Update Active ingredient
section to highlight Acetaminophen and Pain reliever/fever reducer line; Under Do not use,
added a new bullet “if you are allergic to acetaminophen or any of the inactive ingredients in
this product” per FDA Correspondence dated 6/17/09 for NDA 19-872/S-031; Update
Questions or comments? to remove “(English) or 1-888-466-8746 (Spanish)”.
 05/12/2009: Revised Active ingredient section to highlight only the active ingredient;
Update to Warnings sections: replaced Alcohol warning with Liver warning; updated Do
not use and added Ask a doctor before use if you have and Ask a doctor or pharmacist
before use if you are per FDA mandated rule. Updated signature line pertaining to SKUs
manufactured in LP
 03/23/2009: Added signature line pertaining to SKUs packaged in LP.
Page 5 of 7

Formula #: C-85-31, C-85-64, C-85-65
NDC #: 50580-449-XX
 07/22/2008: Addition of Formula, C-85-64 (carnauba wax added to the LP Formula;

both C-85-31 and C-85-64 are manufactured at LP). No change required to inactives.
Update will not affect labeling. Under Other information, update spacing within
storage statement. Added additional instructions for the copyright statement.
 05/07/2007: Updated for EDM system to Box Format. Reordered Titles/Headings prior to
Drug Facts section. Capitalized “INC”.
 02/09/2007: Entered into EDM. Removed Signature section, footer. Under Directions,
removed period after “damage”. Under Distributed by, changed McNeil to MCEIL
 11/27/2006: Formula Updates, C-85-31 and C-85-63; updated Inactive ingredients. Due to
EDM System, reordered Titles/Headings prior to Drug Facts section; removed PDP. Under
Stop use and ask a doctor if, removed the word “for” from the 1st and 2nd bullets; moved “■
redness or swelling is present” to the last bullet.
 05/02/2006: Added PDP; add Formula #s (C-85-63 – FW/BASF; C-85-31 – Las Piedras).
Moved 1-800 poison control number from within sentence to end of sentence per FDA
feedback (see FDA fax dated 10/03/05 for NDA 19-012/S-037). Added additional
instructions for the expiry statement information. Under Questions or comments?, removed
ending period. Company name change. Additional instructions to the copyright statement.
(Please Note: additional copyright information added to LIS closes out QN06-0021).
 10/03/2005: Under Stop use and ask a doctor if section, reordered bullets, and added
“These could be signs of a serious condition.” Under Directions, replaced “as needed” with
“while symptoms last” per the TFM. Removed TYLENOL. Under Other information,
reversed order of bullets per FDA Guidelines January ’05. Removed “toll-free”. Renamed
document, drug facts 449-451-444 100305.doc.
 04/13/2005: Added poison control number to overdose warning per American Association of
Poison Control Centers (AAPCC) guideline.
 02/02/2005: Combination drug facts allow BASF and LP formulations. Include Retail and
hosp/gov NDCs. Change arthritis to minor pain of arthritis and menstrual to premenstrual
Page 6 of 7

Formula #: C-85-31, C-85-64, C-85-65
NDC #: 50580-449-XX
and menstrual cramps in uses section. Reorder uses section. Remove “end” from expiry
statement. . Add “do not use more than 10 days unless directed by a doctor” in 12 years to the
Directions section to make consistent with proposed monograph per 21 CFR 310.201
(a)(1)(7). Remove “end” from expiry statement. Add Distributed by to company
name/address. Add “*contains one or more of these ingredients” to the inactive section;
mark non-shared ingredients with *. Remove Extra Strength from directions for children
under 12 years.
 10/27/2004: Uses C-85-63 and C-85-31.
Page 7 of 7

TYLENOL® Extra Strength Caplets2

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TYLENOL® Extra Strength Caplets2

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Doc ID: J0105229 Version:2.

TYLENOL® Extra Strength Caplets

Use if applicable – do not type instructions that are shaded.

TYLENOL® Extra Strength Caplets

children under 12 years ask a doctor

TYLENOL® Extra Strength Caplets

TYLENOL® Extra Strength Caplets

 07/20/2015: updated company signature line

 09/30/2013: Removed “CONTAINS ACETAMINOPHEN…” statement prior to Drug

 04/03/2013: Added “CONTAINS ACETAMINOPHEN…” statement prior to Drug Facts

TYLENOL® Extra Strength Caplets

 08/06/2010: Updated to rearrange margins

 03/23/2009: Added signature line pertaining to SKUs packaged in LP.

TYLENOL® Extra Strength Caplets

 07/22/2008: Addition of Formula, C-85-64 (carnauba wax added to the LP Formula;

TYLENOL® Extra Strength Caplets

 10/27/2004: Uses C-85-63 and C-85-31.

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