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Infants Pain Relief by Chain Drug Consortium (Premier Value)

Medically reviewed on October 30, 2017

Dosage form: liquid
Ingredients: Acetaminophen 160mg in 5mL
Labeler: Chain Drug Consortium (Premier Value)
NDC Code: 68016-160

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.

Infant's Pain Relief

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purposes

Pain reliever/fever reducer

Uses

temporarily:

  • reduces fever
  • 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, persist 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 is taking the blood thinning drug warfarin.

Ask a Doctor before use if your child has liver disease.

When using this product do not exceed recommended dosage (see overdose warning)

Stop use and ask a doctor if
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or last 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 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 immediately (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
  • shake well before using
  • find right dose on chart. If possible, use weight to dose; otherwise use age.
  • use only the enclosed syringe designed for use with this product. Do not use any other dosing device.
  • remove bottle cap and insert syringe into hole at top of bottle and turn upside down.
  • pull back plunger of syringe until syringe filled slightly over prescribed level.

Turn to original position, simply push plunger back until you have reached the prescribed level. Pull syringe out of the bottle.

  • dispense liquid slowly into baby's mouth, toward the inner cheek.
  • if needed repeat dose every 4 hours while symptoms last.
  • do not use more than 5 times in 24 hours (see overdose warning).
  • replace cap tightly to maintain child resistance.
Dosing Chart
Weight (lb)Age (yr)Dose (mL)
under 24under 2 yearsask a doctor
24-352-3 years5 mL

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

Other information
  • store at controlled room temperature
  • each 5 mL contains: sodium 2 mg

Inactive ingredients

Carboxymethylcellulose, Flavor, Glycerin, High Fructose Corn Syrup, Methyl Paraben, Microcrystal Cellulose, Polyethylene Glycol 1450, Propyl Paraben, Propylene Glycol, Purified Water, Saccharin Sodium, Sorbitol, Sucralose, 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 - 59 mL Bottle Label

NDC 68016-160-02

Premier
Value ®

Infants'
Pain Relief

PAIN RELIEVER - FEVER REDUCER
ACETAMINOPHEN

SUSPENSION LIQUID
•  Dye Free
•  Alcohol Free
•  Aspirin Free

Use only with
enclosed syringe

Cherry Flavor

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

2 FL OZ (59 mL)

INFANTS PAIN RELIEF 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-160
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Xanthan Gum 
Carboxymethylcellulose 
Cellulose, Microcrystalline 
Methylparaben 
Propylparaben 
Sucralose 
Saccharin Sodium 
Propylene Glycol 
Polyethylene Glycol 1450 
High Fructose Corn syrup 
Glycerin 
Sorbitol 
Water 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-160-021 BOTTLE, PLASTIC in 1 CARTON
159 mL in 1 BOTTLE, PLASTIC
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/FEIOperations
davAgen Pharmaceutical, LLC967545935MANUFACTURE(68016-160), PACK(68016-160), LABEL(68016-160), ANALYSIS(68016-160)

 
Chain Drug Consortium (Premier Value)

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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