INFANTS IBUPROFEN - ibuprofen suspension
Aurohealth LLC
----------
Active ingredient (in each 1.25 mL)
Ibuprofen USP 50 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
temporarily:
Allergy alert
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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 your child:
Heart attack and stroke warning
NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Dosing Chart
Weight (lb)
| Age (mos)
| Dose (mL)
|
under 6 mos
| ask a doctor
|
|
12 to 17 lbs
| 6 to 11 mos
| 1.25 mL
|
18 to 23 lbs
| 12 to 23 mos
| 1.875 mL
|
Other information
acesulfame potassium, art raspberry flavor (contains propylene glycol), citric acid anhydrous, FD&C Red No. 40, glycerin, hypromellose, noncrystallizing sorbitol solution, polysorbate 80, pregelatinized starch (potato), purified water, sodium benzoate, sucrose, xanthan gum
Call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/19/1993
AUROHEALTH
NDC 58602-227-07
For Ages 6 Mos. to 23 Mos.
Concentrated Infants' Drops
Ibuprofen Oral Suspension,
USP (NSAID)
50 mg per 1.25 mL
Pain Reliever/Fever Reducer (NSAID)
Concentrated Drops
Lasts up to 8 hours
Use only with enclosed syringe.
Berry Flavor
1 fl oz (30 mL)
AUROHEALTH
NDC 58602-227-07
#Compare to the active ingredient
in Motrin® Infants' Drops
See New Warnings
For Ages 6 Mos. to 23 Mos.
Concentrated
Infants' Drops
Ibuprofen Oral
Suspension, USP
(NSAID)
50 mg per 1.25 mL
Pain Reliever/
Fever Reducer (NSAID)
Concentrated Drops
Lasts up to 8 hours
Use only
with
enclosed
syringe.
Berry Flavor
1 fl oz (30 mL)
INFANTS IBUPROFEN
ibuprofen suspension |
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Labeler - Aurohealth LLC (078728447) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Aurobindo Pharma Limited | 918917642 | ANALYSIS(58602-227) , MANUFACTURE(58602-227) |