OTC Medication Information: Infants Pain Reliever

INFANTS PAIN RELIEVER- acetaminophen suspension
Rij Pharmaceutical Corporation

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.

Active ingredient (in each 1.6 mL = 2 droppersful)

Acetaminophen 160 mg

Purpose

Fever reducer/ pain reliever

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 nonprescription). 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; taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems

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 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.
  • fill to dose level. Do not use any other dosing device.
  • dispense liquid slowly into child’s mouth, toward inner cheek.
  • if needed, repeat dose every 4 hours while symptoms last.
  • do not give use than 5 times in 24 hours
  • replace original bottle cap to maintain child resistance
  • use only with enclosed dropper
  • rinse dropper after each use

Dosing Chart

Weight (lbs.) Age (yrs.) Dose ( mL)
under 24 under 2 ask a doctor
24-35 2-3 2 droppersful (0.8 + 0.8 mL)

Attention: Specifically designed for use with enclosed dropper. Use only enclosed dropper to dose this product. Do not use any other dosing devices.

Other information

TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING
shake well before use.
Store at room Temperature 15º — 30ºC (59º — 86ºF)
protect from freezing.

Inactive ingredients

butyl paraben, cellulose, citric acid, FD&C Blue # 1 FD&C Red # 33, glycerin, high fructose corn syrup, propylene glycol, sodium benzoate, sorbitol, water, xanthan gum

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INFANTS PAIN RELIEVER
acetaminophen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53807-220
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (acetaminophen) Acetaminophen 160 mg in 1.6 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLPARABEN
POWDERED CELLULOSE
CITRIC ACID MONOHYDRATE
D&C RED NO. 33
FD&C BLUE NO. 1
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
PROPYLENE GLYCOL
SODIUM BENZOATE
SODIUM CITRATE
XANTHAN GUM
SORBITOL
WATER
Product Characteristics
Color PURPLE Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53807-220-05 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 15 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (53807-220-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 03/16/1999
Labeler — Rij Pharmaceutical Corporation (144679156)
Establishment
Name Address ID/FEI Operations
Rij Pharmaceutical Corporation 144679156 manufacture (53807-220)

Revised: 05/2018 Rij Pharmaceutical Corporation

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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