DYE FREE 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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DYE FREE CHILDREN'S ACETAMINOPHEN
ORAL SUSPENSION

Grape Flavor

160 mg/5 mL

For Hospital Use Only

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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

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 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

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

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

Other information

Inactive ingredients

anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate

Alcohol Free
Aspirin Free
Dye Free, Non-Staining
Gluten Free
Ibuprofen Free

How Supplied

NDC 68094-015-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-015-62
5 mL per unit dose cup
Thirty (30) cups per shipper

Distributed By
Perrigo Company
Allegan, MI 49010

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

LI1091 Rev. 03/17

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

NDC 68094-015-59
PrecisionDoseā„¢

Children's ACETAMINOPHEN
Oral Suspension
160 mg/5 mL
DYE
FREE

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

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
DYE FREE CHILDRENS ACETAMINOPHEN 
acetaminophen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68094-015(NDC:0113-0397)
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)  
calcium sulfate, unspecified form (UNII: WAT0DDB505)  
carrageenan (UNII: 5C69YCD2YJ)  
glycerin (UNII: PDC6A3C0OX)  
microcrystalline cellulose (UNII: OP1R32D61U)  
carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sorbitol (UNII: 506T60A25R)  
sucralose (UNII: 96K6UQ3ZD4)  
sodium phosphate, tribasic (UNII: A752Q30A6X)  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68094-015-62 3 in 1 CASE 01/13/2017
1 10 in 1 TRAY
1 NDC:68094-015-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2 NDC:68094-015-61 10 in 1 CASE 08/17/2017
2 10 in 1 TRAY
2 NDC:68094-015-59 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 01/13/2017
Labeler - Precision Dose, Inc. (035886746)

Revised: 8/2017
Document Id: 6bd7d768-3924-4bff-a2ed-0f5319110554
Set id: 86961ee1-7f04-4bb6-a9a0-0337f7978122
Version: 2
Effective Time: 20170821
 
Precision Dose, Inc.