Label: INFANTS PAIN RELIEVER- acetaminophen suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 53807-220-05 - Packager: Rij Pharmaceutical Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated May 2, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 1.6 mL = 2 droppersful)
- Purpose
- Uses
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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
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
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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
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INFANTS PAIN RELIEVER
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53807-220 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D) Acetaminophen 160 mg in 1.6 mL Inactive Ingredients Ingredient Name Strength BUTYLPARABEN (UNII: 3QPI1U3FV8) POWDERED CELLULOSE (UNII: SMD1X3XO9M) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) XANTHAN GUM (UNII: TTV12P4NEE) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Product Characteristics Color PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53807-220-05 1 in 1 CARTON 03/16/1999 1 15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 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 Business Operations Rij Pharmaceutical Corporation 144679156 manufacture(53807-220)
