DrugCite

QPAP INFANTS DROPS - acetaminophen syrup 
Qualitest Pharmaceuticals

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

This is an image of the carton for the Q-PAP Infant's Drops.

QPAP INFANTS DROPS 
acetaminophen  syrup
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0603-0838
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 80 mg  in 0.8 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLPARABEN  
CITRIC ACID  
FD&C YELLOW NO. 6  
GLYCERIN  
POLYETHYLENE GLYCOL  
PROPYLENE GLYCOL  
WATER  
SACCHARIN SODIUM  
SODIUM CITRATE  
Product Characteristics
Color ORANGE (clear, orange) Score     
Shape Size
Flavor FRUIT Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0603-0838-73 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
1 15 mL In 1 BOTTLE, PLASTIC This package is contained within the CARTON (0603-0838-73)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 10/01/2023

Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
Name Address ID/FEI Operations
Vintage Pharmaceuticals-Huntsville 958430845 MANUFACTURE
Revised: 05/2010Qualitest Pharmaceuticals