Pediacare Single Dose Fever Reducer
FDA Label NDC 63029-010

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Pediacare Single Dose Fever Reducer (NDC 63029-010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses:, warnings, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if your child is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

(in each 5 mL)

Acetaminophen 160 mg

(in each 5 mL)

Acetaminophen 160 mg

Purpose

Fever reducer/pain reliever

Fever reducer/pain reliever

Uses:

temporarily

  • reduces fever
  • relieves minor aches and pains due to:
          ○ the common cold
          ○ flu
          ○ headache
          ○ sore throat
          ○ toothache

    • temporarily

    • reduces fever
    • relieves minor aches and pains due to:
            ○ the common cold
            ○ flu
            ○ headache
            ○ sore throat
            ○ toothache

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.

    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.
    • 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.

Ask A Doctor Before Use If Your Child Has

liver disease.

liver disease.

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin.

taking the blood thinning drug warfarin.

When Using This Product

do not exceed recommended dosage (see overdose warning)

do not exceed recommended dosage (see overdose warning)

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.

    • 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.

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.

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.

•       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

•       Store at room temperature

•       See bottom panel for lot number and expiration date

•       Keep this box for future reference

•       Store at room temperature

•       See bottom panel for lot number and expiration date

•       Keep this box for future reference

Inactive Ingredients

citric acid, FD&C red no.40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose/carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol, sucralose, xanthan gum

citric acid, FD&C red no.40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose/carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-888-474-3099 Mon.-Fri. 8 am to 8 pm EST PediaCare.com

1-888-474-3099 Mon.-Fri. 8 am to 8 pm EST PediaCare.com

Principal Display Panel

Children Ages 6-8
or 48-59 lbs
PediaCare Squeezable Packet
Fever Reducer
Pain Reliever
Acetaminophen
160mg/5mL
Oral Suspension
6 Single Dose Packets
0.34 FL OZ (10 mL) EACH

Children Ages 6-8or 48-59 Lbspediacare Squeezable Packetfever Reducerpain Relieveracetaminophen 160mg/5mloral Suspension6 Single Dose Packets0.34 Fl Oz (10 mL) Each (Pediacare Single Dose Fever Reducer 01)

Children Ages 6-8or 48-59 Lbspediacare Squeezable Packetfever Reducerpain Relieveracetaminophen 160mg/5mloral Suspension6 Single Dose Packets0.34 Fl Oz (10 mL) Each (Pediacare Single Dose Fever Reducer 01)

CHILDREN
Ages 4-5 NEW!
or 36-47 lbs

Drug Facts

Children Ages 4-5
or 36-47 lbs
PediaCare Squeezable Packet
Fever Reducer
Pain Reliever
Acetaminophen
160mg/5mL
Oral Suspension
7 Single Dose Packets
0.25 FL OZ (7.5 mL) EACH

Children Ages 4-5or 36-47 Lbspediacare Squeezable Packetfever Reducerpain Relieveracetaminophen 160mg/5mloral Suspension7 Single Dose Packets0.25 Fl Oz (7.5 mL) Each (Pediacare Single Dose Fever Reducer 02)

Children Ages 4-5or 36-47 Lbspediacare Squeezable Packetfever Reducerpain Relieveracetaminophen 160mg/5mloral Suspension7 Single Dose Packets0.25 Fl Oz (7.5 mL) Each (Pediacare Single Dose Fever Reducer 02)

* Please review the disclaimer below.