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Childrens 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: 68016-103

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.

Children's Pain Relief

Drug Facts

Active ingredient (in each 5 mL, 1 teaspoon)

Acetaminophen 160 mg

Purpose

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, 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
  • 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 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
  • this product does not contain directions or complete warnings for adult use
  • shake well before using
  • find right dose on chart below. If possible, use weight to dose: otherwise, use age.
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device
  • tsp = teaspoon, mL = milliliter
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
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
  • store at controlled room temperature
  • dosage cup provided
  • each teaspoon contains: sodium 2 mg

Inactive ingredients

Carboxymethylcellulose, FD & C Red # 40, 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 68016-103-04

Premier
Value ®

Children's
Pain Relief

PAIN RELIEVER - FEVER REDUCER
ACETAMINOPHEN
SUSPENSION DROPS

  • Alcohol Free
  • Aspirin Free
  • Ibuprofen Free

Cherry
Flavor

4 FL OZ (118 mL)

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

CHILDRENS PAIN RELIEF 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-103
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 
FD&C Red No. 40 
Water 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-103-041 BOTTLE, PLASTIC in 1 CARTON
1118 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(68016-103), PACK(68016-103), LABEL(68016-103), ANALYSIS(68016-103)

 
Chain Drug Consortium (Premier Value)

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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