JR STRENGTH TYLENOL - acetaminophen tablet, chewable 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc

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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Drug Facts

Active ingredient (in each tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Sore throat warning

if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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 your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has liver disease

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

When using this product do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

  • pain gets worse or lasts more than 5 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.

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. 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

Weight (lb)Age (yr)Dose (tablets) *
*
or as directed by a doctor
under 48under 6 yearsask a doctor
48-596-8 years2 tablets
60-719-10 years2½ tablets
72-9511 years3 tablets

Other information

Inactive ingredients

anhydrous citric acid, cellulose acetate, crospovidone, D&C red no. 7 calcium lake, D&C red no. 30 aluminum lake, dextrose excipient, FD&C blue no. 1 aluminum lake, flavor, magnesium stearate, povidone, sucralose

Questions or comments?

call 1-877-895-3665

PRINCIPAL DISPLAY PANEL

NDC 50580-514-24

Jr. TYLENOL®

Acetaminophen
Pain Reliever-Fever Reducer

For Children
AGES 6-11

∙ MEDICINE PER TABLET ∙
160
mg

Meltaways

24 Chewable Tablets

Aspirin Free ∙ Ibuprofen Free

Grape Punch
flavor

PRINCIPAL DISPLAY PANEL

JR STRENGTH TYLENOL 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-514
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen160 mg
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
cellulose acetate 
crospovidone 
D&C red no. 7 
D&C red no. 30 
FD&C blue no. 1 
aluminum oxide 
magnesium stearate 
povidone 
sucralose 
Product Characteristics
ColorPURPLEScore2 pieces
ShapeROUNDSize16mm
FlavorGRAPEImprint Code TY;160
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:50580-514-244 BLISTER PACK in 1 CARTONcontains a BLISTER PACK
16 TABLET, CHEWABLE in 1 BLISTER PACKThis package is contained within the CARTON (50580-514-24)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34308/01/2004

Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)

Revised: 04/2012 McNeil Consumer Healthcare Div. McNeil-PPC, Inc