QPAP INFANTS DROPS- acetaminophen syrup 
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.

----------

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0838
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg  in 0.8 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorORANGE (clear, orange) Score    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-0838-731 in 1 CARTON10/01/199712/31/2014
115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34310/01/199712/31/2014
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIBusiness Operations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE(0603-0838)

Revised: 5/2010
 
Qualitest Pharmaceuticals