Your browser does not support JavaScript! CARE ONE IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]
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CARE ONE IBUPROFEN INFANTS (ibuprofen) suspension
[American Sales Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Active ingredient (in each 1.25 mL)

Ibuprofen 50 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

temporarily:

reduces fever
relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

hives
facial swelling
asthma (wheezing)
shock
skin reddening
rash
blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the child:

has had stomach ulcers or bleeding problems
takes a blood thinning (anticoagulant) or steroid drug
takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
takes more or for a longer time than directed

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

Do not use

if the child has ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery

Ask a doctor before use if

stomach bleeding warning applies to your child
child has a history of stomach problems, such as heartburn
child has problems or serious side effects from taking pain relievers or fever reducers
child has not been drinking fluids
child has lost a lot of fluid due to vomiting or diarrhea
child has high blood pressure, heart disease, liver cirrhosis, or kidney disease
child has asthma
child is taking a diuretic

Ask a doctor or pharmacist before use if the child is

under a doctor’s care for any serious condition
taking any other drug

When using this product

give with food or milk if stomach upset occurs
the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

child experiences any of the following signs of stomach bleeding:
feels faint
vomits blood
has bloody or black stools
has stomach pain that does not get better
the child does not get any relief within first day (24 hours) of treatment
fever or pain gets worse or lasts more than 3 days
redness or swelling is present in the painful area
any new symptoms appear

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

this product does not contain directions or complete warnings for adult use
do not give more than directed
shake well before using
find right dose on chart below. If possible, use weight to dose; otherwise use age.
measure with the dosing device provided. Do not use with any other device.
dispense liquid slowly into the child’s mouth, toward the inner cheek
if needed, repeat dose every 6-8 hours
do not use more than 4 times a day

Dosing Chart

Weight (lbs)

Age (mos)

Dose (mL)

under 6 mos

ask a doctor

12-17 lbs

6-11 mos

1.25 mL

18-23 lbs

12-23 mos

1.875 mL

Other information

store at 20-25°C (68-77°F)
do not freeze
do not use if printed neckband is broken or missing
see bottom of box for lot number and expiration date

Inactive ingredients

anhydrous citric acid, artificial flavor, butylparaben, FD&C red #40, glycerin, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in Motrin® Infants’ Drops

For Ages 6 to 23 mos.

INFANTS'

CONCENTRATED DROPS

IBUPROFEN ORAL SUSPENSION

50 mg per 1.25 mL

PAIN RELIEVER/FEVER REDUCER (NSAID)

BERRY FLAVOR

Lasts up to 8 hours

Alcohol Free

Use Only with Enclosed Syringe

See New Warnings Information

Ibuprofen Oral Suspension Carton Image 1
Ibuprofen Oral Suspension Carton Image 2
CARE ONE IBUPROFEN  INFANTS
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-057
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN50 mg  in 1.25 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
BUTYLPARABEN 
FD&C RED NO. 40 
GLYCERIN 
HYPROMELLOSES 
POLYSORBATE 80 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCROSE 
XANTHAN GUM 
Product Characteristics
ColorPINK (light) Score    
ShapeSize
FlavorFRUIT (mixed) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-057-051 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07521705/11/2004
Labeler - American Sales Company (809183973)

Revised: 10/2012
 
American Sales Company

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