Acetaminophen: Package Insert and Label Information

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.

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

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

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

Distributed By
Perrigo
Allegan, MI 49010

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 -- 20.3 mL Cup LabelPRINCIPAL DISPLAY PANEL — 20.3 mL Cup Label

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 -- 10.15 mL Cup LabelPRINCIPAL DISPLAY PANEL — 10.15 mL Cup Label

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

PRINCIPAL DISPLAY PANEL -- 5 mL Cup LabelPRINCIPAL DISPLAY PANEL — 5 mL Cup Label
ACETAMINOPHEN acetaminophen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68094-030
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 650 mg in 20.3 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid
butylparaben
calcium sulfate, unspecified form
carrageenan
D&C red no. 33
FD&C blue no. 1
glycerin
high fructose corn syrup
microcrystalline cellulose
carboxymethylcellulose sodium, unspecified form
propylene glycol
water
sodium benzoate
sorbitol
sodium phosphate, tribasic
Product Characteristics
Color PURPLE Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68094-030-62 3 TRAY in 1 CASE contains a TRAY
1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (68094-030-62) and contains a CUP, UNIT-DOSE (68094-030-59)
1 NDC:68094-030-59 20.3 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (68094-030-62)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 325 mg in 10.15 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid
butylparaben
calcium sulfate, unspecified form
carrageenan
D&C red no. 33
FD&C blue no. 1
glycerin
high fructose corn syrup
microcrystalline cellulose
carboxymethylcellulose sodium, unspecified form
propylene glycol
water
sodium benzoate
sorbitol
sodium phosphate, tribasic
Product Characteristics
Color PURPLE Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68094-330-62 3 TRAY in 1 CASE contains a TRAY
1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (68094-330-62) and contains a CUP, UNIT-DOSE (68094-330-59)
1 NDC:68094-330-59 10.15 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (68094-330-62)
2 NDC:68094-330-61 10 TRAY in 1 CASE contains a TRAY
2 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (68094-330-61) and contains a CUP, UNIT-DOSE (68094-330-59)
2 NDC:68094-330-59 10.15 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (68094-330-61)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 160 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid
butylparaben
calcium sulfate, unspecified form
carrageenan
D&C red no. 33
FD&C blue no. 1
glycerin
high fructose corn syrup
microcrystalline cellulose
carboxymethylcellulose sodium, unspecified form
propylene glycol
water
sodium benzoate
sorbitol
sodium phosphate, tribasic
Product Characteristics
Color PURPLE Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68094-231-62 3 TRAY in 1 CASE contains a TRAY
1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (68094-231-62) and contains a CUP, UNIT-DOSE (68094-231-59)
1 NDC:68094-231-59 5 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (68094-231-62)
2 NDC:68094-231-61 10 TRAY in 1 CASE contains a TRAY
2 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (68094-231-61) and contains a CUP, UNIT-DOSE (68094-231-59)
2 NDC:68094-231-59 5 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (68094-231-61)
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 Operations
Precision Dose, Inc. 035886746 REPACK (68094-030), REPACK (68094-330), REPACK (68094-231)
Establishment
Name Address ID/FEI Operations
L Perrigo Company 006013346 MANUFACTURE (68094-030), MANUFACTURE (68094-330), MANUFACTURE (68094-231)

Revised: 03/2020 Precision Dose, Inc.

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