CHILDRENS QPAP - acetaminophen solution 
Qualitest Pharmaceuticals

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Childrens Q-PAP Acetaminophen Liquid 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.

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 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
• do not give for more than 5 days unless directed by a doctor

Weight (lb)	Age (yr)	Dose (tsp or mL)
under 24 lbs	under 2 years	ask a doctor
24-35 lbs	2-3 years	1 tsp or 5 mL
36-47 lbs	4-5 years	1 ½ tsp or 7.5 mL
48-59 lbs	6-8 years	2 tsp or 10 mL
60-71 lbs	9-10 years	2 ½ tsp or 12.5 mL
72-95 lbs	11 years	3 tsp or 15 mL

Other information

• each 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. 7/09 R7
8073416 0840

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

CHILDRENS QPAP  acetaminophen   solution

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0603-0840 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength D&C RED NO. 33   FD&C BLUE NO. 1   GLYCERIN   POLYETHYLENE GLYCOL   PROPYLENE GLYCOL   WATER   SODIUM BENZOATE   SORBITOL   SUCROSE

Product Characteristics Color PURPLE (clear, purple) Score      Shape Size Flavor GRAPE Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0603-0840-94 118 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	06/01/1997

Labeler - Qualitest Pharmaceuticals (011103059)

Establishment
Name	Address	ID/FEI	Operations
Vintage Pharmaceuticals-Huntsville		958430845	MANUFACTURE

Revised: 05/2010Qualitest Pharmaceuticals