CHILDRENS QPAP- acetaminophen solution 
Qualitest Pharmaceuticals

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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Children's Q-PAP Acetaminophen Oral Solution Cherry Flavor

Active ingredient (in each 5 mL = 1 tsp)

Acetaminophen, USP 160 mg

Purpose

Pain reliever/ fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
  • temporarily reduces fever

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)
  • mL = milliliter; tsp = teaspoonful
  • find right dose on chart below. 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
*
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)

Attention: Specifically designed for use with enclosed measuring cup. Use only enclosed measuring cup to dose this product. Do not use any other dosing device.

Other information

  • each 5 mL (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 red #40, 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 R10
8273405  0839

PRINCIPAL DISPLAY PANEL

This is an image of the carton for the Children's Q-Pap Liquid.
CHILDRENS QPAP 
acetaminophen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0839
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorRED (clear, red) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-0839-541 in 1 CARTON03/01/199812/31/2014
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:0603-0839-58473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/199812/31/2014
3NDC:0603-0839-94118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/199812/31/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34303/01/199812/31/2014
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIBusiness Operations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE(0603-0839)

Revised: 8/2012
 
Qualitest Pharmaceuticals