CHILDRENS ACETAMINOPHEN   - acetaminophen suspension 
ParaPRO LLC

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NDC 52246-023-04

Children's Acetaminophen

oral suspension

80 mg per 1/2 teaspoon (160 mg per 5 mL)

fever reducer/pain releiver

4 FL OZ (118 mL)

Purpose

Pain reliever/fever reducer

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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, as a doctor or pharmacist.

Ask a doctor before use if you 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

• do not give more than directed (see Liver warning)
• shake well before using
• find right dose on chart.  If possible, use weight to dose; otherwise, use age.
• use only enclosed dosing cup designed for use with this product.  Do not use any other dosing device
• • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
  • this product does not contain directions or complete warnings for adult use

Weight (lb)          Age (yr)             Dose (tsp or mL)
 Under 24            Under 2 years               ask a doctor
   24-35                   2-3 years                 1 tsp or 5 mL
   36-47                   4-5 years              1 1/2 tsp or 7.5 mL
   48-59                   6-8 years                 2 tsp or 10 mL
   60-71                  9-10 years             2 1/2 tsp or 12.5 mL
   72-95                    11 years                  3 tsp or 15 mL
     
Attention:  use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information:

• each teaspoon contains:  sodium 3 mg
• store at 20o - 25oC (68o - 77oF)

Questions? Call 317-580-8267

DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.

Inactive ingredients:  anhydrous citric acid, butylparaben, caboxymethylcellulose sodium, carrageenan, D and C red no. 33, FD and C blue no.1, flavor, glycerin, high fructose corn syrup, hodroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution

Active ingredient (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Bottle Label

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Carton Label

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Uses temporarily:

• reduces fever
• relieve minor aches and pain due to:
• • the common cold
  • flu
  • headache
  • sore throat
  • toothache

CHILDRENS ACETAMINOPHEN   acetaminophen   suspension

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 52246-023 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (Acetaminophen) Acetaminophen 32 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength anhydrous citric acid   butylparaben   carboxymethylcellulose sodium   carrageenan   D&C red no. 33   FD&C blue no. 1   glycerin   high fructose corn syrup   HYDROXYETHYL CELLULOSE (140 CPS AT 5%)   CELLULOSE, MICROCRYSTALLINE   propylene glycol   water   sodium benzoate   sorbitol

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

Packaging # NDC Package Description Multilevel Packaging 1 52246-023-04 1 BOTTLE In 1 CARTON contains a BOTTLE 1 118 mL In 1 BOTTLE This package is contained within the CARTON (52246-023-04)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/03/2011	05/16/2011

Labeler - ParaPRO LLC (186639006)

Establishment
Name	Address	ID/FEI	Operations
ParaPRO LLC		186639006	manufacture

Revised: 05/2011ParaPRO LLC