INFANTS ACETAMINOPHEN - acetaminophen for suspension 
Precision Dose Inc.

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INFANTS' ACETAMINOPHEN
CONCENTRATED SUSPENSION

Cherry Flavor

40 mg/0.4 mL
80 mg/0.8 mL
200 mg/2 mL

For Hospital Use Only

Drug Facts

Active Ingredient (in each 0.8 mL)

Acetaminophen 80 mg

Purpose

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 product 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

• use as directed per healthcare professional
• do not give more than directed (see Liver warning)
• 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
• this product does not contain directions or complete warnings for adult use

Other Information

• 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, 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

Alcohol Free, Aspirin Free, Ibuprofen Free

IMPORTANT

Concentrated Infants' Drops contains more medicine per drop than Children's Liquid.

How Supplied

NDC 68094-581-58
0.4 mL per unit dose syringe
Fifty (50) unit dose syringes per shipper

NDC 68094-692-58
0.8 mL per unit dose syringe
Fifty (50) unit dose syringes per shipper

NDC 68094-703-58
2 mL per unit dose syringe
Fifty (50) unit dose syringes per shipper

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

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

LI712 Rev. 05/10

PRINCIPAL DISPLAY PANEL - 80 mg / 0.8 mL Syringe Label

Infant's ACETAMINOPHEN
Concentrated Suspension

80 mg / 0.8 mL   Delivers 0.8 mL

Store at 20°-25°C (68°-77°F)
Hospital Use Only
Alcohol Free   Aspirin Free   Ibuprofen Free

LSY734 Rev. 09/08

PRINCIPAL DISPLAY PANEL - 200 mg / 2 mL Syringe Label

Infants' ACETAMINOPHEN
Concentrated Suspension

200 mg / 2 mL   Delivers 2 mL

Store at 20°-25°C (68°-77°F)
Hospital Use Only
Alcohol Free   Aspirin Free   Ibuprofen Free

LSY787 Rev. 05/09

INFANTS ACETAMINOPHEN  acetaminophen   for suspension

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 68094-692 (0113-0289) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (Acetaminophen) Acetaminophen 80 mg  in 0.8 mL

Inactive Ingredients Ingredient Name Strength Anhydrous citric acid   butylparaben   Carboxymethylcellulose sodium   carrageenan   sodium benzoate   sorbitol   FD&C red no. 40   Glycerin   high fructose corn syrup   cellulose, microcrystalline   propylene glycol   water

Product Characteristics Color PINK Score      Shape Size Flavor CHERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68094-692-58 50 BAG In 1 CASE contains a BAG 1 1 SYRINGE In 1 BAG This package is contained within the CASE (68094-692-58) and contains a SYRINGE, PLASTIC 1 0.8 mL In 1 SYRINGE, PLASTIC This package is contained within a BAG and a CASE (68094-692-58)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/15/2009

INFANTS ACETAMINOPHEN  acetaminophen   for suspension

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 68094-703 (0113-0289) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (Acetaminophen) Acetaminophen 200 mg  in 2 mL

Inactive Ingredients Ingredient Name Strength Anhydrous citric acid   butylparaben   Carboxymethylcellulose sodium   carrageenan   sodium benzoate   sorbitol   FD&C red no. 40   Glycerin   high fructose corn syrup   cellulose, microcrystalline   propylene glycol   water

Product Characteristics Color PINK Score      Shape Size Flavor CHERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68094-703-58 50 BAG In 1 CASE contains a BAG 1 1 SYRINGE In 1 BAG This package is contained within the CASE (68094-703-58) and contains a SYRINGE, PLASTIC 1 2 mL In 1 SYRINGE, PLASTIC This package is contained within a BAG and a CASE (68094-703-58)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/15/2010

Labeler - Precision Dose Inc. (035886746)

Revised: 01/2011Precision Dose Inc.