CONCENTRATED TYLENOL INFANTS- acetaminophen suspension/ drops 
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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Concentrated TYLENOL®
Infants

Drug Facts

Active ingredient (in each 0.8 mL)

Acetaminophen 80 mg

Purpose

Fever reducer/pain reliever

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
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
  • use only enclosed dropper designed for use with this product. Do not use any other dosing device.
  • fill to dose level
  • dispense liquid slowly into child's mouth, toward inner cheek
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
  • replace dropper tightly to maintain child resistance
Dosing Chart
Weight (lb)Age (yr)Dose (mL)
under 24under 2 yearsask a doctor
24-352-3 years1.6 mL (0.8 + 0.8 mL)

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

Other information

  • store between 20-25°C (68-77°F)
  • do not use if carton tape imprinted "Safety Seal®" or bottle wrap imprinted "Safety Seal®" and "Use with Enclosed Dosing Device" is broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

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

Questions or comments?

call 1-877-895-3665

PRINCIPAL DISPLAY PANEL

See New Warnings Information

NDC 50580-144-40

Concentrated
TYLENOL
®

Infants' Drops

Acetaminophen

Fever Reducer, Pain Reliever

INFANTS

Pediatricians'
1st Choice

Alcohol Free

Aspirin Free

Ibuprofen Free

Grape FLAVOR

1/4 FL OZ (7.5 mL)
80 mg per 0.8 mL

USE ONLY
Enclosed Dropper

Principal Display Panel
CONCENTRATED TYLENOL INFANTS 
acetaminophen suspension/ drops
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50580-144
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (acetaminophen) Acetaminophen80 mg  in 0.8 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
D&C red no. 33 
FD&C blue no. 1 
glycerin 
high fructose corn syrup 
cellulose, microcrystalline 
carboxymethylcellulose sodium 
water 
sodium benzoate 
sorbitol 
xanthan gum 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-144-151 in 1 CARTON
115 mL in 1 BOTTLE, PLASTIC
2NDC:50580-144-181 in 1 CARTON
215 mL in 1 BOTTLE, PLASTIC
3NDC:50580-144-401 in 1 CARTON
37.5 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/01/200510/25/2013
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 4/2014
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc