PediaCare Single Dose Fever Reducer description, usages, side effects, indications, overdosage, supplying and lots more!

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PediaCare Single Dose Fever Reducer

Medtech Products Inc.

PediaCare Single Dose Fever Reducer




FULL PRESCRIBING INFORMATION

CHILDREN
Ages 6-8 NEW!
or 48-59 lbs

Drug Facts

(in each 5 mL )

Acetaminophen 160 mg

Fever reducer/pain reliever

temporarily

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

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.

  • 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.

liver disease.

taking the blood thinning drug warfarin.

do not exceed recommended dosage (see overdose warning)

  • 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.

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.

•       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.

•       Store at room temperature

•       See bottom panel for lot number and expiration date

•       Keep this box for future reference

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

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

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

PediaCare Single Dose Fever Reducer

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

Drug Facts

(in each 5 mL )

Acetaminophen 160 mg

Fever reducer/pain reliever

temporarily

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

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.

  • 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.

liver disease.

taking the blood thinning drug warfarin.

do not exceed recommended dosage (see overdose warning)

  • 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.

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.

•       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.

•       Store at room temperature

•       See bottom panel for lot number and expiration date

•       Keep this box for future reference

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

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

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

PediaCare Single Dose Fever Reducer

PediaCare Single Dose Fever Reducer

Acetaminophen LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63029-075
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
cellulose, microcrystalline
POTASSIUM SORBATE
water
sorbitol
XANTHAN GUM
Sucralose

Product Characteristics

Color
RED

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 7.5 in 1 DOSE PACK
2 NDC:63029-075-07 7 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2013-05-15


PediaCare Single Dose Fever Reducer

Acetaminophen LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63029-010
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
cellulose, microcrystalline
POTASSIUM SORBATE
water
sorbitol
XANTHAN GUM
Sucralose

Product Characteristics

Color
RED

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 DOSE PACK
2 NDC:63029-010-10 6 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2013-05-15


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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