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Childrens Acetaminophen by Rij Pharmaceutical Corporation

Medically reviewed on April 30, 2018

Dosage form: elixir
Ingredients: Acetaminophen 160mg in 5mL
Labeler: Rij Pharmaceutical Corporation
NDC Code: 53807-196

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.

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
    • immunizations
    • 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 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
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

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. Quick medical attention is critical for adults as well as for children 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.
  • if needed, repeat dose every 4 hours
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
  • only use enclosed measuring cup
Weight (lbs.)Age (yrs.)Dose (tsp or mL)
under 24under 2ask a doctor
24-352-3 years1 tsp or 5 mL
36-474-5 years1½ tsp or 7.5 mL
48-596-8 years2 tsp or 10 mL
60-719-10 years2½ tsp or 12.5 mL
72-9511 years3 tsp or 15 mL

Other information
Store at room temperature 15º - 30ºC (59º - 86ºF)
Protect from Freezing.
Protect from Light.
each teaspoon (5 mL) contains: sodium 7 mg
TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING

Inactive ingredients

citric acid, FD&C red # 40, FD&C blue # 1, flavor, glycerin. PEG 400, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water.

PRINCIPAL DISPLAY PANEL

CHILDRENS ACETAMINOPHEN 
acetaminophen elixir
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-196
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (acetaminophen) Acetaminophen160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
SODIUM BENZOATE 
SODIUM CITRATE 
SACCHARIN SODIUM 
SORBITOL 
WATER 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPE (GRAPE) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53807-196-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34303/16/1999
Labeler - Rij Pharmaceutical Corporation (144679156)
Establishment
NameAddressID/FEIOperations
Rij Pharmaceutical Corporation144679156manufacture(53807-196)

 
Rij Pharmaceutical Corporation

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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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