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Cardinal Health

Cardinal Health Concentrated Pain Reliever Infants' Drops Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 0.8 mL)

Acetaminophen 80 mg

Purpose

Fever reducer/pain reliever

leader 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.

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

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.

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

  • 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 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
  • this product does not contain directions or complete warnings for adult use
Dosing Chart
Weight(lb) Age(yr) Dose (mL)
under 24 under 2 years ask a doctor
24-35 2–3 years 1.6 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 at 20°-25°C (68°-77°F)
  • do not use if printed bottle wrap is broken or missing

Inactive ingredients

anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution

Questions or comments?

1-800-719-9260

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Compare to Concentrated Tylenol® Infants’ Drops active ingredient

Up to Age 3

Concentrated

Pain Reliever

Infants' Drops

Acetaminophen

Fever Reducer

Pain Reliever

Cherry Flavor

Use Only with Enclosed Dropper

80 mg per 0.8 mL

leader pain reliever
Concentrated Pain Reliever Infants' Drops Carton

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Acetaminophen SUSPENSION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37205-008
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 80 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
BUTYLPARABEN
CARBOXYMETHYLCELLULOSE SODIUM
CARRAGEENAN
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
cellulose, microcrystalline
propylene glycol
water
SODIUM BENZOATE
sorbitol

Product Characteristics

Color
RED (opaque)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BOTTLE, DROPPER
2 NDC:37205-008-05 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 1990-05-15


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