ACETAMINOPHEN suspension

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Precision Dose, Inc., L Perrigo Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product

Allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

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 you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if the user has liver disease

Ask a doctor or pharmacist before use if the user 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 10 days (for adults) or 5 days (for children)
• 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.

• do not give this product to children for the pain of arthritis unless directed by a doctor

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• Use as directed per healthcare professional.
• do not take more than directed (see overdose warning)
• shake well before using
• find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
• repeat dose every 4 hours while symptoms last
• do not take more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (mL)*
* or as directed by a doctor
Under 24	Under 2 years	ask a doctor
24-35	2-3 years	5 mL
36-47	4-5 years	7.5 mL
48-59	6-8 years	10 mL
60-71	9-10 years	12.5 mL
72-95	11 years	15 mL
Over 96	adults and children 12 years and over	20 mL

Other information

• each 5 mL contains: sodium 3 mg
• store at 20-25°C (68-77°F)

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

SPL UNCLASSIFIED SECTION

Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free

How Supplied

NDC: 68094-130-58
2.5 mL per unit dose syringe
Fifty (50) syringes per shipper

NDC: 68094-231-58
5 mL per unit dose syringe
Fifty (50) syringes per shipper

NDC: 68094-231-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC: 68094-231-62
5 mL per unit dose cup
Thirty (30) cups per shipper

NDC: 68094-330-61
10.15 mL per unit dose cup
One hundred (100) cups per shipper

NDC: 68094-330-62
10.15 mL per unit dose cup
Thirty (30) cups per shipper

NDC: 68094-030-62
20.3 mL per unit dose cup
Thirty (30) cups per shipper

QUESTIONS

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

SPL UNCLASSIFIED SECTION

Distributed By
Perrigo
Allegan, MI 49010

SPL UNCLASSIFIED SECTION

Packaged By
Precision Dose, Inc.
South Beloit, IL 61080

LI1263 Rev. 10/19

PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Label

NDC: 68094-030-59

PrecisionDose™

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

Hospital Use Only
Store at 20°-25°C (68°-77°F)
Pkg. By: Precision Dose, Inc.
S. Beloit, IL 61080
1262 R0

PRINCIPAL DISPLAY PANEL - 10.15 mL Cup Label

NDC: 68094-330-59

PrecisionDose™

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

Hospital Use Only
Store at 20°-25°C (68°-77°F)
Pkg. By: Precision Dose, Inc.
South Beloit, IL 61080
1303 R0

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

NDC: 68094-231-59

PrecisionDose™

ACETAMINOPHEN
Oral Suspension
160 mg/5 mL

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

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68094-030
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
butylparaben (UNII: 3QPI1U3FV8)
calcium sulfate, unspecified form (UNII: WAT0DDB505)
carrageenan (UNII: 5C69YCD2YJ)
D&C red no. 33 (UNII: 9DBA0SBB0L)
FD&C blue no. 1 (UNII: H3R47K3TBD)
glycerin (UNII: PDC6A3C0OX)
high fructose corn syrup (UNII: XY6UN3QB6S)
microcrystalline cellulose (UNII: OP1R32D61U)
carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
sodium phosphate, tribasic (UNII: A752Q30A6X)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68094-030-62	3 in 1 CASE	09/06/2019
1		10 in 1 TRAY
1	NDC: 68094-030-59	20.3 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	09/06/2019

ACETAMINOPHEN 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68094-330
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
butylparaben (UNII: 3QPI1U3FV8)
calcium sulfate, unspecified form (UNII: WAT0DDB505)
carrageenan (UNII: 5C69YCD2YJ)
D&C red no. 33 (UNII: 9DBA0SBB0L)
FD&C blue no. 1 (UNII: H3R47K3TBD)
glycerin (UNII: PDC6A3C0OX)
high fructose corn syrup (UNII: XY6UN3QB6S)
microcrystalline cellulose (UNII: OP1R32D61U)
carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
sodium phosphate, tribasic (UNII: A752Q30A6X)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68094-330-62	3 in 1 CASE	01/15/2020
1		10 in 1 TRAY
1	NDC: 68094-330-59	10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 68094-330-61	10 in 1 CASE	01/15/2020
2		10 in 1 TRAY
2	NDC: 68094-330-59	10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	01/15/2020

ACETAMINOPHEN 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68094-231
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
butylparaben (UNII: 3QPI1U3FV8)
calcium sulfate, unspecified form (UNII: WAT0DDB505)
carrageenan (UNII: 5C69YCD2YJ)
D&C red no. 33 (UNII: 9DBA0SBB0L)
FD&C blue no. 1 (UNII: H3R47K3TBD)
glycerin (UNII: PDC6A3C0OX)
high fructose corn syrup (UNII: XY6UN3QB6S)
microcrystalline cellulose (UNII: OP1R32D61U)
carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
sodium phosphate, tribasic (UNII: A752Q30A6X)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68094-231-62	3 in 1 CASE	04/01/2020
1		10 in 1 TRAY
1	NDC: 68094-231-59	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 68094-231-61	10 in 1 CASE	04/01/2020
2		10 in 1 TRAY
2	NDC: 68094-231-59	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	04/01/2020

Labeler - Precision Dose, Inc. (035886746)

Establishment
Name	Address	ID/FEI	Business Operations
Precision Dose, Inc.		035886746	REPACK(68094-030, 68094-330, 68094-231)

Establishment
Name	Address	ID/FEI	Business Operations
L Perrigo Company		006013346	MANUFACTURE(68094-030, 68094-330, 68094-231)