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Childrens Acetaminophen by Precision Dose Inc.

Medically reviewed on October 20, 2017

Dosage form: suspension
Ingredients: Acetaminophen 160mg in 5mL
Labeler: Precision Dose Inc.
NDC Code: 68094-586

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.

CHILDREN'S ACETAMINOPHEN ORAL SUSPENSION

Grape Flavor

80 mg/2.5 mL   160 mg/5 mL   325 mg/10.15 mL

For Hospital Use Only

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 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
  • use as directed per healthcare professional
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see overdose warning)
  • shake cups well before using
  • mL = milliliter
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb)Age (yr)Dose (mL)
or as directed by a doctor
under 24under 2 yearsask a doctor
24-352-3 years5 mL
36-474-5 years7.5 mL
48-596-8 years10 mL
60-719-10 years12.5 mL
72-9511 years15 mL

Other information
  • each 5 mL contains: sodium 3 mg
  • store at 20-25°C (68-77°F)
  • see individual label or shipper for lot number and expiration date

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 68094-586-58
2.5 mL per unit dose syringe
Fifty (50) syringes per shipper

NDC 68094-587-58
5 mL per unit dose syringe
Fifty (50) syringes per shipper

NDC 68094-587-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-587-62
5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-588-62
10.15 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

LI950 Rev. 03/17

PRINCIPAL DISPLAY PANEL - 2.5 mL Syringe Label

Children's ACETAMINOPHEN
Oral Suspension

80 mg / 2.5 mL Delivers 2.5 mL

Store at 20°-25°C (68°-77°F)
Hospital Use Only
Alcohol Free Aspirin Free
Gluten Free Ibuprofen Free

For Oral Use Only

CHILDRENS ACETAMINOPHEN 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-586(NDC:0113-0212)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68094-586-5850 BAG in 1 CASE
11 SYRINGE, PLASTIC in 1 BAG
12.5 mL in 1 SYRINGE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/30/2014
Labeler - Precision Dose Inc. (035886746)

 
Precision Dose Inc.

← See all Childrens Acetaminophen brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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