Childrens Acetaminophen

Precision Dose Inc.

CHILDREN'S ACETAMINOPHEN ORAL SUSPENSION

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredient (in each 5 mL = 1 teaspoonful)
• Purpose
• Childrens Acetaminophen Uses
• Warnings
  • Liver warning
  • Sore throat warning
  • Do not use
  • Overdose warning
• Directions
• Other Information
• Inactive Ingredients
• How Supplied
• PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

FULL PRESCRIBING INFORMATION

Grape Flavor

40 mg/1.25 mL  80 mg/2.5 mL   160 mg/5 mL   325 mg/10.15 mL

For Hospital Use Only

Drug Facts

Active Ingredient (in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliever/Fever reducer

Childrens Acetaminophen 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 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 even if you do not notice any signs or symptoms.

Directions

• Use as directed per healthcare professional.
• this product does not contain directions or complete warnings for adult use
• do not give more than directed (see overdose warning)
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours
• shake cups well before using

Other Information

• each 5 mL (1 tsp) contains: sodium 3 mg
• store at 20°- 25°C (68°-77°F)
• see individual label or shipper label for lot number and expiration date.

Inactive Ingredients

anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate

Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free

How Supplied

NDC 68094-585-58
1.25 mL per unit dose syringe
Fifty (50) unit dose syringes per shipper

NDC 68094-586-58
2.5 mL per unit dose syringe
Fifty (50) unit dose syringes per shipper

NDC 68094-587-58
5 mL per unit dose syringe
Fifty (50) unit dose syringes per shipper

NDC 68094-587-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-587-62
5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-588-62
10.15 mL per unit dose cup
Thirty (30) cups per shipper

Manufactured By:
Perrigo Company
515 Eastern Avenue
Allegan, MI 49010

Packaged By:
Precision Dose, Inc.
722 Progressive Lane
South Beloit, IL 61080

LI 950
Rev. 02/14

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

NDC 68094-587-59

PrecisionDose ™

Children's ACETAMINOPHEN
Oral Suspension
160 mg/5 mL

Pkg: Precision Dose, Inc., S. Beloit, IL 61080