Sunmark Infants Pain and Fever description, usages, side effects, indications, overdosage, supplying and lots more!

Sunmark Infants Pain and Fever

McKesson

  • 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
McKesson Infants Pain & Fever Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL)

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 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

When using this product

do not exceed recommended does (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 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
  • •find right dose on chart. If possible, use weight to dose; otherwise, use age.
  • •push air out of syringe. Firmly push syringe into bottle opening.
  • •turn bottle upside down. Pull syringe to the first dose line and then push product back into bottle.
  • •pull syringe until it reaches and stays at the correct dose
  • •dispense liquid slowly into child’s mouth, toward inner cheek
  • •repeat dose every 4 hours while symptoms last
  • •do not give more than 5 times in 24 hours
  • •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

*or as directed by a doctor

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

Other information

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

Inactive ingredients

anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, FD&C red #40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

COMPARE TO INFANTS’ TYLENOL® ORAL SUSPENSION ACTIVE INGREDIENT

See New Dosage & Directions

Infants’

pain & fever

Acetaminophen

Pain reliever

Fever reducer

Suspension Liquid

Aspirin Free

Ibuprofen Free

Alcohol Free

Use only with enclosed syringe

Pediatrician Preferred Dosing System

See side panel for more information

CHARRY FLAVOR

GLUTEN FREE

2 FL OZ 59 mL

160 mg per 5 mL

Sunmark Infants Pain and Fever

Acetaminophen LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49348-081
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
CALCIUM SULFATE
CARRAGEENAN
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
cellulose, microcrystalline
CARBOXYMETHYLCELLULOSE SODIUM
propylene glycol
water
SODIUM BENZOATE
sorbitol
SODIUM PHOSPHATE, TRIBASIC

Product Characteristics

Color
RED

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 59 in 1 BOTTLE
2 NDC:49348-081-30 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2011-10-25


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Be sure to consult your doctor before taking any medication!
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