Dolofin Infantil description, usages, side effects, indications, overdosage, supplying and lots more!

Dolofin Infantil

Menper Distributors, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert



FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient

Acetaminophen 160 mg

Purpose

Purpose

Acetaminophen.............................Pain reliever/fever reducer

Uses

Uses

temporarily reduces fever
temporarily 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.

Ask a doctor before use if your child has

liver disease.

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

When using this product

• do not exceed recommended dose
(see overdose warning)

Stop use and ask a doctor if

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
These could be signs of a serious condition.

Keep this and all drugs out of the reach of children.

Overdose Warning: Taking more than the
recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek
professional assistance or contact a Poison Control
Center immediately. 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.
• shake well before using
• find right dose on chart below. If possible, use
weight to dose; otherwise, use age.
• use only enclosed dosing cup designed for use
with this product. Do not use any other dosing
device.
• if needed, repeat dose every 4 hours while
symptoms last
• do not give more than 5 times in 24 hours
• do not give more than 5 days unless directed
by a doctor

Weight (lb)  Age (yr)  Dose (tsp or mL)
under 24          under 2              ask a doctor
24-35                2-3             1 teaspoon or 5 mL
36-47                4-5          1 1/2 teaspoons or 7.5 mL
48-59                6-8           2 teaspoons or 10 mL
60-71               9-10         2 1/2 teaspoons or 12.5 mL
72-95                 11            3 teaspoons or 15 mL

Other information

• store at controlled room temperature
• see bottom panel for lot number and
expiration date

Inactive Ingredients

acesulfame potassium, butyl paraben,
carboxymethylcellulose sodium, cellulose, citric acid,
flavors, glycerin, high fructose corn syrup, propylene
glycol, purified water, red 40, sodium benzoate,
sorbitol, xanthan gum

Dolofin Infantil

Acetaminophen LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53145-053
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
BUTYLPARABEN
CARBOXYMETHYLCELLULOSE SODIUM
CITRIC ACID ACETATE
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
propylene glycol
water
SODIUM BENZOATE
sorbitol
Sucralose
XANTHAN GUM

Product Characteristics

Color
red

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 120 in 1 BOTTLE
2 NDC:53145-053-03 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2012-02-21


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