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Childrens QPAP by Qualitest Pharmaceuticals

Dosage form: solution
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: Qualitest Pharmaceuticals
NDC Code: 0603-0840

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 Q-Pap Acetaminophen Oral Solution Grape

Active ingredient (in each 5 mL = 1 tsp)

Acetaminophen, USP 160 mg

Purpose

Pain reliever/ fever reducer

Uses
  • temporarily reduces fever
  • temporarily 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product

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: Taking more than the recommended dose (overdose) may cause liver damage. 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

this product does not contain directions or complete warnings for adult use

  • do not give more than directed (see overdose warning)
  • use an accurate measuring device to administer this medication
  • mL = milliliter; tsp = teaspoonful
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
or as directed by a doctor
 Weight (lb) Age (yr) Dose (mL or tsp) 
 under 24 under 2 years ask a doctor
 24-35 2-3 years

 5 mL (1 tsp)

 36-47 4-5 years 7.5 mL (1 ½ tsp)

 48-59

 6-8 years

 10 mL (2 tsp)

 60-71

 9-10 years

 12.5 mL (2 ½ tsp)
 72-95 11 years 15 mL (3 tsp)

Other information
  • each 5mL (1 tsp) contains: sodium 2 mg
  • store at 15º to 30ºC (59º to 86ºF)

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

D&C red #33, FD&C blue #1, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 9/11 R9
8073416 0840

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

CHILDRENS QPAP 
acetaminophen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0840
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
FD&C BLUE NO. 1 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCROSE 
Product Characteristics
ColorPURPLE (clear, purple) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0603-0840-94118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34306/01/1997
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIOperations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE(0603-0840)

Revised: 08/2012
 
Qualitest Pharmaceuticals

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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