QPAP Infants Drops

Dosage form: syrup
Ingredients: ACETAMINOPHEN 80mg in 0.8mL
Labeler: Qualitest Pharmaceuticals
NDC Code: 0603-0838

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.

Q-PAP Infants Drops Acetaminophen Fruit Flavor

Active ingredient (in each 0.8 mL)

Acetaminophen, USP 80 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
    • the common cold
    • flu
    • headaches
    • sore throat
    • toothaches

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; taking more than the  recommended dose (overdose) may not provide more relief and may cause liver damage.

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 even if you do not notice any signs or symptoms.

Directions

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

  • find right dose on chart. (If possible, use weight to dose; otherwise, use age.)
  • use only enclosed dropper for use with this product. Do not use any other dosing device.
  • fill to dose level
  • dispense liquid slowly into child’s mouth, toward inner cheek
  • if needed, repeat dose every 4 hours while symptoms last
  • do not use more than 5 times in 24 hours
  • replace dropper tightly to maintain child resistance

 Weight
(lbs)

Age
(yrs)

Dose
(mL)

under 24

under 2 

ask a doctor

24-35 

2-3

1.6 mL (0.8+0.8 mL)

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

Other information

store at 15° to 30°C (59° to 86°F)

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

Inactive ingredients

butylparaben, citric acid, FD&C yellow #6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 6/09 R10
8273411  0838

PRINCIPAL DISPLAY PANEL
QPAP INFANTS DROPS 
acetaminophen syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0838
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN80 mg  in 0.8 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN 
CITRIC ACID 
FD&C YELLOW NO. 6 
GLYCERIN 
POLYETHYLENE GLYCOL 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM CITRATE 
Product Characteristics
ColorORANGE (clear, orange) Score    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0603-0838-731 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON
115 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34310/01/1997
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIOperations
Vintage Pharmaceuticals-Huntsville958430845MANUFACTURE

Revised: 05/2010
 
Qualitest Pharmaceuticals

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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