GOOD SENSE PAIN RELIEFCHILDRENS CHILDRENS- acetaminophen suspension 
Aidarex Pharmaceuticals LLC

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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Perrigo Children’s Pain Relief Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

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 has ever had an allergic reaction to this product or any of its ingredients

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 even if you do not notice any signs or symptoms.

Directions

 

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)

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

Inactive ingredients

anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate

Questions or comments?

1-800-719-9260

Principal Display Panel

For Ages 2 – 11

Children’s

Pain Relief

Acetaminophen Oral Suspension

Fever Reducer/Pain Reliever

Suspension Liquid

Alcohol Free

Aspirin Free

Ibuprofen Free

Grape Flavor

Compare to active ingredient of Children’s Tylenol® Oral Suspension

160 mg per 5 mL

IMAGE LABEL

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

GOOD SENSE PAIN RELIEFCHILDRENS  CHILDRENS
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33261-770(NDC:0113-0130)
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
CALCIUM SULFATE (UNII: WAT0DDB505)  
SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)  
Product Characteristics
ColorPURPLE (viscous) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33261-770-011 in 1 CARTON
1118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34302/25/1993
Labeler - Aidarex Pharmaceuticals LLC (801503249)

Revised: 11/2013
Document Id: 2af6c8f6-8041-421c-943a-7ee745600a9a
Set id: 45ddd71d-de6c-4e21-a22a-0b37afcc429b
Version: 1
Effective Time: 20131112
 
Aidarex Pharmaceuticals LLC