CHILDRENS PAIN RELIEF- acetaminophen liquid 
Chain Drug Consortium (Premier Value)

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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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

  • 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 non-prescription). 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 the child is taking the blood thinning drug warfarin

When using this product

Stop use and ask a doctor if

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts for more than 3 days. These could be signs of a serious condition.

Keep this and all drugs out of the reach of children.

Overdose Warning

Taking more than the recommended dose (overdose) could cause serious health problems including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

Weight (lb)Age (yr)Dose (tsp or mL)
under 24under 2ask a doctor
24-352-31 tsp or 5 mL
36-474-51½ tsps or 7.5 mL
48-596-82 tsps or 10 mL
60-719-102½ tsps or 12.5 mL
72-95113 tsps or 15 mL

Other information

Inactive ingredients

Carboxymethylcellulose, FD&C Blue #1, D&C Red #33, Flavors, Glycerin, High Fructose Corn Syrup, Methylparaben, Microcrystalline Cellulose, Polyethylene Glycol 1450, Propylene Glycol, Propylparaben, Purified Water, Saccharin Sodium, Sorbitol Solution, Sucralose Powder, Xanthan Gum

Questions or comments?

1-732-249-6363

DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 68016-141-04

Premier
Value ®

Children's
Pain Relief

PAIN RELIEVER - FEVER REDUCER
ACETAMINOPHEN
SUSPENSION LIQUID

• Alcohol Free
• Aspirin Free
• Ibuprofen Free

Grape
Flavor

4 FL OZ (118 mL)

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

Principal Display Panel - 118 mL Bottle Label
CHILDRENS PAIN RELIEF 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-141
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
Xanthan Gum (UNII: TTV12P4NEE)  
Carboxymethylcellulose (UNII: 05JZI7B19X)  
Powdered Cellulose (UNII: SMD1X3XO9M)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Sucralose (UNII: 96K6UQ3ZD4)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Polyethylene Glycol 1450 (UNII: OJ4Z5Z32L4)  
High Fructose Corn Syrup (UNII: XY6UN3QB6S)  
Glycerin (UNII: PDC6A3C0OX)  
Sorbitol (UNII: 506T60A25R)  
D&C Red No. 33 (UNII: 9DBA0SBB0L)  
FD&C Blue No. 2 (UNII: L06K8R7DQK)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-141-041 in 1 CARTON
1118 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 FINALpart34310/03/2014
Labeler - Chain Drug Consortium (Premier Value) (101668460)
Registrant - davAgen Pharmaceutical, LLC (967545935)
Establishment
NameAddressID/FEIBusiness Operations
davAgen Pharmaceutical, LLC967545935MANUFACTURE(68016-141) , PACK(68016-141) , LABEL(68016-141) , ANALYSIS(68016-141)

Revised: 10/2014
Document Id: fc3a8014-1886-40f7-8c7e-5ae4fe359450
Set id: e697cdaf-b842-41ed-bb05-a324de0533d8
Version: 1
Effective Time: 20141027
 
Chain Drug Consortium (Premier Value)