Label: PEDIACARE SINGLE DOSE FEVER REDUCER- acetaminophen liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 63029-010-10, 63029-075-07 - 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 15, 2013
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:
-
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 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.
Stop use and ask a doctor if:
- pain gets worse or lasts for more than 5 days.
- fever gets worse or lasts for more than 3 days.
- new symptoms occur.
- redness or swelling is present.
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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
- more than 5 doses in 24 hours, which is the maximum daily amount
-
Directions
• This product does not contain directions or complete warnings for adult use.
• Each packet provides 1 dose for a child who is 48 to 59 pounds or 6 to 8 years of age. If possible, use weight to determine dose; otherwise use age.
To use:
• Fold back at the dotted line to reveal the tear strip.
• Tear across (not up & down) at the exposed tear slit
• Remove and discard strip
• Squeeze medicine into child’s mouth.
• If needed, repeat dose every 4 hours while symptoms last.
• Do not give more than 5 times in 24 hours (see overdose warning).
• Do not give more than 5 days unless directed by a doctor.
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
- 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
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 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.
Stop use and ask a doctor if:
- pain gets worse or lasts for more than 5 days.
- fever gets worse or lasts for more than 3 days.
- new symptoms occur.
- redness or swelling is present.
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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
- more than 5 doses in 24 hours, which is the maximum daily amount
-
Directions
• This product does not contain directions or complete warnings for adult use.
• Each packet provides 1 dose for a child who is 36 to 47 pounds or 4 to 5 years of age. If possible, use weight to determine dose; otherwise use age.
To use:
• Fold back at the dotted line to reveal the tear strip.
• Tear across (not up & down) at the exposed tear slit
• Remove and discard strip
• Squeeze medicine into child’s mouth.
• If needed, repeat dose every 4 hours while symptoms last.
• Do not give more than 5 times in 24 hours (see overdose warning).
• Do not give more than 5 days unless directed by a doctor.
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PEDIACARE SINGLE DOSE FEVER REDUCER
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-075 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) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color RED Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-075-07 7 in 1 BOX, UNIT-DOSE 1 7.5 mL in 1 DOSE PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 05/15/2013 PEDIACARE SINGLE DOSE FEVER REDUCER
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-010 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) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color RED Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-010-10 6 in 1 BOX, UNIT-DOSE 1 10 mL in 1 DOSE PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 05/15/2013 Labeler - Medtech Products Inc. (122715688)
