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  5. Label Information: Pediacare Single Dose Fever Reducer

FDA Label for Pediacare Single Dose Fever Reducer

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES:
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF:
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL

Pediacare Single Dose Fever Reducer Product Label

The following document was submitted to the FDA by the labeler of this product Medtech Products Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.