Childrens TYLENOL description, usages, side effects, indications, overdosage, supplying and lots more!

Childrens TYLENOL

McNeil Consumer Healthcare Div. McNeil-PPC, Inc

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Children's TYLENOL

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

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 pour 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 24 under 2 years ask a doctor
24-35 2-3 years 5 mL (1 tsp)
36-47 4-5 years 7.5 mL (1½ tsp)
48-59 6-8 years 10 mL (2 tsp)
60-71 9-10 years 12.5 mL (2½ tsp)
72-95 11 years 15 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

Inactive ingredients

anhydrous citric acid, butylparaben, D&C red no. 33, FD&C blue no. 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 1-800-458-1635 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 50580-164-04

FOR IN-PATIENT
HOSPITAL USE ONLY

Children's
TYLENOL®

Acetaminophen
Pain Reliever - Fever Reducer
Oral Suspension

Alcohol Free
Aspirin Free
Ibuprofen Free
Grape Flavor

Not for Retail Sale

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

PRINCIPAL DISPLAY PANEL

Childrens TYLENOL

acetaminophen SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50580-164
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg

Inactive Ingredients

Ingredient Name Strength
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

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 120 in 1 BOTTLE, PLASTIC
2 NDC:50580-164-04 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2014-06-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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