Label: PEDIACARE INFANTS FEVER REDUCER DYE FREE- acetaminophen liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 52183-383-01 - Packager: Blacksmith Brands, Inc.
- Category: HUMAN OTC DRUG LABEL
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 October 8, 2010
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if the 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, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- with any other product 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.
- more than 5 doses in 24 hours, which is the maximum daily amount
- Overdose warning:
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Directions
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do not give more than directed (see overdose warning)
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shake well before use
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this product does not contain directions or complete warnings for adult use
- use only with enclosed dosing device
- fill to dose level
- dispense liquid slowly into child’s mouth towards inner cheek
- repeat dose every 4 hours if needed
- do not give more than 5 times in 24 hours
- do not give for more than 5 days unless directed by a doctor
- use dropper to close bottle and maintain child resistance
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
Weight (lb) Age (yr) Dose (mL) Under 24 Under 2 ask a doctor 24-35 2-3 1.6 mL (0.8 + 0.8 mL) -
do not give more than directed (see overdose warning)
- Other information
- Inactive ingredients:
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PEDIACARE INFANTS FEVER REDUCER DYE FREE
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-383 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg in 0.8 mL Inactive Ingredients Ingredient Name Strength BUTYLPARABEN (UNII: 3QPI1U3FV8) CITRIC ACID (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) MALTITOL (UNII: D65DG142WK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52183-383-01 1 in 1 BOX 1 30 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 07/28/2010 Labeler - Blacksmith Brands, Inc. (021411299) Establishment Name Address ID/FEI Business Operations Guardian Drug Company 119210276 MANUFACTURE