topcare infants pain and fever description, usages, side effects, indications, overdosage, supplying and lots more!

topcare infants pain and fever

Topco Associates LLC

  • 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
Topco Associates LLC. Infants' Pain & Fever Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purposes

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 has ever had an allergic reaction to this product or any of its ingredients

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

  • 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.

Directions

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Liver warning)
  • shake well before using
  • find right dose on chart. If possible, use weight to dose; otherwise use age.
  • use only enclosed syringe designed for use with this product. Do not use any other dosing device.
  • remove bottle cap and insert syringe tip through opening at top of the bottle
  • tip the bottle upside down and draw medicine into the syringe
  • 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 cap tightly to maintain child resistance
Dosing Chart
Weight (lb) Age (yr) Dose (mL)
under 24 under 2 years ask a doctor
24-35 2-3 years 5 mL

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

  • store at 20-25ºC (68-77ºF)  
  • do not use if printed bottle wrap is broken or missing

anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate

Questions or comments

1-888-423-0139

Package/Label Principal Display Panel

SEE NEW DOSAGE & DIRECTIONS

SUSPENSION LIQUID

Infants' Pain & Fever

ACETAMINOPHEN

Fever Reducer

Pain Reliever

Aspirin free

Alcohol free

Ibuprofen free

Non-staining

Use only with enclosed syringe

Pediatrician Preferred Dosing System

DYE-FREE

CHERRY FLAVOR

No high fructose corn syrup

COMPARE TO INFANTS' TYLENOL® SUSPENSION LIQUID active ingredient

160 mg per 5 ml

Package/Label Principal Display Panel
Infants' Pain & Fever Carton Image 1 Infants' Pain & Fever Carton Image 2

topcare infants pain and fever

acetaminophen LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-590
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
CALCIUM SULFATE
CARRAGEENAN
GLYCERIN
cellulose, microcrystalline
CARBOXYMETHYLCELLULOSE SODIUM
propylene glycol
PROPYLPARABEN
water
SODIUM BENZOATE
sorbitol
Sucralose
SODIUM PHOSPHATE, TRIBASIC

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE
2 NDC:36800-590-16 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 1993-07-21


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Be sure to consult your doctor before taking any medication!
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