Label: LITTLE FEVERS INFANT BERRY FEVER/PAIN RELIEVER- acetaminophen liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 63029-622-01 - Packager: Medtech Products Inc.
- 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 July 2, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- 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.
Do not use:
- with any other products 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.
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.
When using this product
DO NOT EXCEED RECOMMENDED DOSAGE; taking more than the recommended dose (overdose) may not provide more relief and may cause liver damage.
- more than 5 doses in 24 hours, which is the maximum daily amount
- Overdose
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Directions
This product does not contain directions or complete warnings for adult use.
- Shake well before using.
- Find the right dose on the chart below. (If possible, use weight to determine dose; otherwise, use age.)
- Only use the enclosed AccuSafeTM syringe.
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Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
- Remove cap, attach syringe to flow restrictor and invert bottle.
- Pull back syringe until filled to prescribed level and slowly dispense the liquid into your child’s mouth (toward the inner cheek).
- If needed, repeat dose every 4 hours while symptoms last.
- Do not give more than 5 times in any 24-hour period (see overdose warning).
- Replace cap tightly to maintain child resistance.
Weight (lbs) Age (yrs) Dose Under 24 Under 2 Ask a doctor 24-35 2-3 5.0 mL 36-47 4-5 7.5 mL - Shake well before using.
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LITTLE FEVERS INFANT BERRY FEVER/PAIN RELIEVER
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-622 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color WHITE Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-622-01 1 in 1 BOX 1 1 in 1 BOX 1 59 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 07/01/2011 Labeler - Medtech Products Inc. (122715688)
