CHILDRENS TYLENOL- acetaminophen tablet, chewable

Childrens Tylenol by

Drug Labeling and Warnings

Childrens Tylenol by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • the common cold
  • flu
  • headache
  • sore throat
  • toothache
• temporarily reduces fever

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

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.

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

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

• this product does not contain directions or complete warnings for adult use.
• do not give more than directed (see overdose warning)
• find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• chew tablets completely before swallowing; do not swallow tablets whole
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (tablets)*
* or as directed by a doctor
under 24	under 2 years	ask a doctor
24-35	2-3 years	1 tablet
36-47	4-5 years	1½ tablets
48-59	6-8 years	2 tablets
60-71	9-10 years	2½ tablets
72-95	11 years	3 tablets

Other information

• store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
• do not use if neck band or foil inner seal imprinted with "TYLENOL" is broken or missing

Inactive ingredients

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

Questions or comments?

call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC: 50580-522-24

Children's
TYLENOL®

New Strength & Directions

Acetaminophen
Pain Reliever
Fever Reducer

Pain+Fever
Ages 2-11

Chewables
Ibuprofen Free, Aspirin Free

Now
160 mg
Per Tablet

Actual Size

24 Chewable Tablets
160 mg each

Grape Flavor

INGREDIENTS AND APPEARANCE

CHILDRENS TYLENOL 
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-522
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	160 mg

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
cellulose acetate (UNII: 3J2P07GVB6)
crospovidone, unspecified (UNII: 2S7830E561)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 30 (UNII: 2S42T2808B)
Aluminum Oxide (UNII: LMI26O6933)
dextrose, unspecified form (UNII: IY9XDZ35W2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
magnesium stearate (UNII: 70097M6I30)
povidone, unspecified (UNII: FZ989GH94E)
sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PURPLE	Score	2 pieces
Shape	ROUND	Size	16mm
Flavor	GRAPE	Imprint Code	TY;160;HALF;HALF
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-522-24	1 in 1 CARTON	02/27/2017
1		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	02/27/2017

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