CHILDRENS ACETAMINOPHEN- acetaminophen suspension
Precision Dose Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Children's Acetaminophen
ORAL SUSPENSION

Grape Flavor

40 mg/1.25 mL 80 mg/2.5 mL 160 mg/5 mL 325 mg/10.15 mL 650 mg/20.3 mL

For Hospital Use Only

Drug Facts

Active Ingredient (in each 5 mL = 1 teaspoonful)

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.

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 overdosage, 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)
shake cups well before using
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

each teaspoon 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, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution

Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free

How Supplied

NDC 68094-582-58
1.25 mL per unit dose syringe
Fifty (50) unit dose syringes per shipper

NDC 68094-583-58
2.5 mL per unit dose syringe
Fifty (50) unit dose syringes per shipper

NDC 68094-593-58
5 mL per unit dose syringe
Fifty (50) unit dose syringes per shipper

NDC 68094-593-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-593-62
5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-614-62
10.15 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-650-62
20.3 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
S. Beloit, IL 61080

LI 806
Rev. 01/12

PRINCIPAL DISPLAY PANEL - 160 mg/5 mL Syringe Label

NDC# 68094-593-58

Children's ACETAMINOPHEN Oral Suspension, 160 mg/5 mL

Delivers 5 mL Hospital Use Only

Alcohol free Aspirin free Ibuprofen free

Each 5 mL contains: Sodium 3 mg Gluten free

Store at 20°-25°C (68°-77°F)

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

LSY844 Rev. 04/12

Patent US 7,972,312 B2

For Oral Use Only

8343

PRINCIPAL DISPLAY PANEL - 160 mg/5 mL Syringe Label

PRINCIPAL DISPLAY PANEL - 325 mg/10.15 mL Cup Lid

NDC 68094-614-59

PrecisionDose™

Children's ACETAMINOPHEN
Oral Suspension
325 mg/10.15 mL

Delivers 10.15 mL Shake Well
Each 5 mL contains Sodium 3 mg
Alcohol Free Aspirin Free Gluten Free Ibuprofen Free

Store at 20°-25°C (68°-77°F)
Pkg. By: Precision Dose, Inc.
S. Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 325 mg/10.15 mL Cup Lid

PRINCIPAL DISPLAY PANEL - 650 mg/20.3 mL Cup Lid

NDC 68094-650-59

PrecisionDose™

Children's ACETAMINOPHEN
Oral Suspension
650 mg/20.3 mL

Delivers 20.3 mL Shake Well
Each 5 mL contains Sodium 3 mg
Alcohol Free Aspirin Free Gluten Free Ibuprofen Free

Store at 20°-25°C (68°-77°F)
Pkg. By: Precision Dose, Inc.
S. Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 650 mg/20.3 mL Cup Lid

CHILDRENS ACETAMINOPHEN
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68094-593
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	160 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
Butylparaben (UNII: 3QPI1U3FV8)
carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)
carrageenan (UNII: 5C69YCD2YJ)
anhydrous citric acid (UNII: XF417D3PSL)
glycerin (UNII: PDC6A3C0OX)
D&C red no. 33 (UNII: 9DBA0SBB0L)
FD&C blue no. 1 (UNII: H3R47K3TBD)
high fructose corn syrup (UNII: XY6UN3QB6S)
cellulose, microcrystalline (UNII: OP1R32D61U)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:68094-593-62	3 in 1 CASE
1		10 in 1 TRAY
1	NDC:68094-593-59	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC:68094-593-61	10 in 1 CASE
2		10 in 1 TRAY
2	NDC:68094-593-59	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
3	NDC:68094-593-58	5 in 1 CASE
3		10 in 1 BAG
3		5 mL in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	10/25/2005	06/30/2015

CHILDRENS ACETAMINOPHEN
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68094-614
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg in 10.15 mL

Ingredient Name	Strength
Inactive Ingredients
Butylparaben (UNII: 3QPI1U3FV8)
carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)
carrageenan (UNII: 5C69YCD2YJ)
anhydrous citric acid (UNII: XF417D3PSL)
glycerin (UNII: PDC6A3C0OX)
D&C red no. 33 (UNII: 9DBA0SBB0L)
FD&C blue no. 1 (UNII: H3R47K3TBD)
high fructose corn syrup (UNII: XY6UN3QB6S)
cellulose, microcrystalline (UNII: OP1R32D61U)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:68094-614-62	3 in 1 CASE
1		10 in 1 TRAY
1	NDC:68094-614-59	10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	03/21/2008	03/31/2015

CHILDRENS ACETAMINOPHEN
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68094-650
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	650 mg in 20.3 mL

Ingredient Name	Strength
Inactive Ingredients
Butylparaben (UNII: 3QPI1U3FV8)
carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)
carrageenan (UNII: 5C69YCD2YJ)
anhydrous citric acid (UNII: XF417D3PSL)
glycerin (UNII: PDC6A3C0OX)
D&C red no. 33 (UNII: 9DBA0SBB0L)
FD&C blue no. 1 (UNII: H3R47K3TBD)
high fructose corn syrup (UNII: XY6UN3QB6S)
cellulose, microcrystalline (UNII: OP1R32D61U)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:68094-650-62	3 in 1 CASE
1		10 in 1 TRAY
1	NDC:68094-650-59	20.3 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	03/21/2008	04/30/2014

Labeler - Precision Dose Inc. (035886746)

Revised: 5/2014

Document Id: 06d402cd-5196-49ce-94db-b161cde65647

Set id: fc65dd9e-2051-455b-ae4c-3e39e9d1fbf0

Version: 4

Effective Time: 20140522

Precision Dose Inc.

Children's Acetaminophen ORAL SUSPENSION

Active Ingredient (in each 5 mL = 1 teaspoonful)

Purpose

Uses

Warnings

Liver warning

Sore throat warning

Directions

Other Information

Inactive Ingredients

How Supplied

PRINCIPAL DISPLAY PANEL - 160 mg/5 mL Syringe Label

PRINCIPAL DISPLAY PANEL - 325 mg/10.15 mL Cup Lid

PRINCIPAL DISPLAY PANEL - 650 mg/20.3 mL Cup Lid

Children's Acetaminophen
ORAL SUSPENSION