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Ibuprofen Infants
Sun Pharmaceutical Industries, Inc.
temporarily:
- reduces fever
- relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
- take with food or milk if stomach upset occurs
- 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.
- mL = milliliter
- 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 to 8 hours
- do not use more than 4 times a day
| Weight (lb) | 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 |
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)
- 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
- child has symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- 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
- under a doctor's care for any serious condition
- taking any other drug
- if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
- right before or after heart surgery
- store between 20° to 25°C (68° to 77°F)
- do not use if carton is opened or if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing
- see bottom panel of carton for lot number and expiration date
*Compare to the active
ingredient in
Motrin
®Infants' Drops
NDC 51672-2146-3
For Ages 6 Mos. to 23 Mos.
Concentrated
Infants' Drops
Ibuprofen
Oral Suspension (NSAID)
50 mg per 1.25 mL
Pain reliever / Fever reducer
Dye-Free
Alcohol Free
Use only with
enclosed
syringe.
Lasts
up to
8 hours
Berry Flavor
1 FL OZ (30 mL)
[image: MM1]What it looks like
Photos of the product and/or packaging supplied by the manufacturer.
Package codes (NDC)
- 51672-2146-3
- 51672-2146-5
Full prescribing information (for healthcare professionals)
SPL UNCLASSIFIED SECTION
Drug Facts
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 your 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
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.
SPL UNCLASSIFIED SECTION
Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532