DOLOFIN INFANTIL- acetaminophen liquid

Dolofin Infantil by

Drug Labeling and Warnings

Dolofin Infantil by is a Otc medication manufactured, distributed, or labeled by Menper Distributors, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Acetaminophen 160 mg

PURPOSE

Purpose

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

INDICATIONS & USAGE

Uses

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

WARNINGS

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 DOCTOR

Ask a doctor before use if your child has

liver disease.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

WHEN USING

When using this product

do not exceed recommended dose
(see overdose warning)

STOP USE

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 OUT OF REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOLOFIN INFANTIL 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-053
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
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

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: 53145-053-03	1 in 1 CARTON
1		120 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	02/21/2012

Labeler - Menper Distributors, Inc. (101947166)