INFANTS 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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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 - 80 mg / 0.8 mL Syringe Label

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

For Oral Use Only

PRINCIPAL DISPLAY PANEL - 200 mg / 2 mL Syringe Label
INFANTS ACETAMINOPHEN 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-692(NDC:0113-0008)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen80 mg  in 0.8 mL
Inactive Ingredients
Ingredient NameStrength
Anhydrous citric acid 
butylparaben 
carboxymethylcellulose sodium 
carrageenan 
FD&C red no. 40 
glycerin 
high fructose corn syrup 
cellulose, microcrystalline 
propylene glycol 
water 
sodium benzoate 
sorbitol 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68094-692-5850 in 1 CASE
11 in 1 BAG
10.8 mL in 1 SYRINGE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/15/200901/31/2013
INFANTS ACETAMINOPHEN 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-703
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen200 mg  in 2 mL
Inactive Ingredients
Ingredient NameStrength
Anhydrous citric acid 
butylparaben 
carboxymethylcellulose sodium 
carrageenan 
FD&C red no. 40 
glycerin 
high fructose corn syrup 
cellulose, microcrystalline 
propylene glycol 
water 
sodium benzoate 
sorbitol 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68094-703-5850 in 1 CASE
11 in 1 BAG
12 mL in 1 SYRINGE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34303/15/201010/31/2012
Labeler - Precision Dose Inc. (035886746)

Revised: 04/2013
Document Id: ba1034bf-7571-4a96-bd66-20ed2e2f9da1
Set id: e06da89a-c581-4c12-85ae-4bb5dd832af9
Version: 3
Effective Time: 20130415
 
Precision Dose Inc.