Your browser does not support JavaScript! CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]
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CHILDRENS TYLENOL (acetaminophen) suspension
[McNeil Consumer Healthcare Div McNeil-PPC, Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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

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

  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter; tsp = teaspoonful
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • remove the child protective cap and squeeze your child's dose into the dosing cup
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb)Age (yr)Dose (mL or tsp) *
*
or as directed by a doctor
under 24under 2 yearsask a doctor
24-352-3 years5 mL (1 tsp)
36-474-5 years7.5 mL (1½ tsp)
48-596-8 years10 mL (2 tsp)
60-719-10 years12.5 mL (2½ tsp)
72-9511 years15 mL (3 tsp)

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

  • each 5 mL (1 tsp) contains: sodium 2 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or if carton tape or bottle wrap imprinted "SAFETY SEAL®" is broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, butylparaben, D&C red #33, FD&C blue #1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

call 1-877-895-3665

PRINCIPAL DISPLAY PANEL

See New Directions

NDC 50580-296-50

Children's
TYLENOL
®

Acetaminophen
Oral Suspension
Pain Reliever-Fever Reducer

PAIN & FEVER
Ages 2-11

Ibuprofen Free
Alcohol Free
Aspirin Free

Grape
Splash

FLAVOR

4 fl oz (120 ml)
160 mg per 5 ml

Principal Display Panel
CHILDRENS TYLENOL 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50580-296
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (acetaminophen) Acetaminophen160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
butylparaben 
D&C red NO. 33 
FD&C blue NO. 1 
glycerin 
high fructose corn syrup 
cellulose, microcrystalline 
carboxymethylcellulose sodium 
propylene glycol 
water 
sodium benzoate 
sorbitol 
sucralose 
xanthan gum 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPE (Grape Splash) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-296-041 in 1 CARTON
1120 mL in 1 BOTTLE
2NDC:50580-296-512 in 1 PACKAGE
2NDC:50580-296-501 in 1 CARTON
2120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/01/2004
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 1/2013
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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