Label: LITTLE REMEDIES CHILDRENS FEVER PAIN RELIEVER- acetaminophen liquid
- NDC Code(s): 63029-602-02, 63029-603-02
- 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 February 14, 2018
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
-
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.
Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If skin reaction occurs, stop use and seek medical help right away.
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 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.
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Directions
This product does not contain directions or complete warnings for adult use.
- Do not give more than directed (see overdose warning).
- Shake well before using.
- Find the right dose on the chart below. (If possible, use weight to determine dosing; otherwise, use age.)
- Pour liquid into AccuSafe® dosing cup to the appropriate amount for your child's weight and/or age.
- Only use with enclosed AccuSafe® dosing cup.
- If needed, repeat dose every 4 hours while symptoms last.
- Do not give more than 5 days in any 24-hour period (see overdose warning).
- Do not give more than 5 days unless directed by a doctor.
- Replace cap tightly to maintain child resistance.
Weight (lb) Age (yr) Dose Under 24 under 2 Ask a doctor 24-35 2 – under 4 5mL 36-47 4 – under 6 7.5mL 48-59 6 – under 9 10 mL 60-71 9 – under 11 12.5mL 72-95 11 – under 12 15mL - Other information
- Inactive ingredients
- Questions?
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INGREDIENTS AND APPEARANCE
LITTLE REMEDIES CHILDRENS FEVER PAIN RELIEVER
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-602 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 MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) 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:63029-602-02 1 in 1 CARTON 09/01/2010 1 118 mL in 1 BOTTLE; 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 09/01/2010 LITTLE REMEDIES CHILDRENS FEVER PAIN RELIEVER
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-603 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 MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-603-02 1 in 1 CARTON 09/01/2010 1 118 mL in 1 BOTTLE; 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 09/01/2010 Labeler - Medtech Products Inc. (122715688)