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NDC 00904-5463-35 ibuprofen 50 mg/1.25mL Details
ibuprofen 50 mg/1.25mL
ibuprofen is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is IBUPROFEN.
MedlinePlus Drug Summary
Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
Related Packages: 00904-5463-35Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ibuprofen
Product Information
| NDC | 00904-5463 |
|---|---|
| Product ID | 0904-5463_30293465-3322-46e1-b3e1-b1d0055624e6 |
| Associated GPIs | 66100020001810 |
| GCN Sequence Number | 023855 |
| GCN Sequence Number Description | ibuprofen DROPS SUSP 50 MG/1.25 ORAL |
| HIC3 | S2B |
| HIC3 Description | NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS |
| GCN | 35931 |
| HICL Sequence Number | 003723 |
| HICL Sequence Number Description | IBUPROFEN |
| Brand/Generic | Generic |
| Proprietary Name | ibuprofen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ibuprofen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/1.25mL |
| Substance Name | IBUPROFEN |
| Labeler Name | Major Pharmaceuticals |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075217 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00904-5463-35 (00904546335)
| NDC Package Code | 0904-5463-35 |
|---|---|
| Billing NDC | 00904546335 |
| Package | 1 BOTTLE in 1 CARTON (0904-5463-35) / 15 mL in 1 BOTTLE |
| Marketing Start Date | 2000-01-08 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.28676 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | INFANT IBUPROFEN 50 MG/1.25 ML |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL b4962985-47e6-4389-874f-76742b086e2f Details
Uses
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- •
- hives
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- facial swelling
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- asthma (wheezing)
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- shock
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- 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:
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- has had stomach ulcers or bleeding problems
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- takes a blood thinning (anticoagulant) or steroid drug
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- takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
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- 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.
Do not use
- •
- if the child has ever had an allergic reaction to ibuprofen or 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
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- 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, kidney disease, or had a stroke
- •
- 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
Stop use and ask a doctor if
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- child experiences any of the following signs of stomach bleeding:
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- feels faint
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- vomits blood
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- has bloody or black stools
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- has stomach pain that does not get better
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- child has symptoms of heart problems or stroke:
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- chest pain
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- trouble breathing
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- weakness in one part or side of body
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- slurred speech
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- leg swelling
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- the child does not get any relief within first day (24 hours) of treatment
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- fever or pain gets worse or lasts more than 3 days
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- redness or swelling is present in the painful area
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- any new symptoms appear
Directions
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- this product does not contain directions or complete warnings for adult use
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- do not give more than directed
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- shake well before using
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- find right dose on chart below. If possible, use weight to dose; otherwise use age.
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- mL = milliliter
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- measure with the dosing device provided. Do not use with any other device.
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- 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
Inactive ingredients
Principal Display Panel
For Ages 6 mos. to 23 mos.
Infants’ Ibuprofen
Oral Suspension
50 mg per 1.25 mL
Pain Reliever/Fever Reducer (NSAID)
Lasts up to 8 hours
See New Warnings
Use only with enclosed syringe
Berry Flavored
No High Fructose Corn Syrup
Infants’ Concentrated Drops
COMPARE TO the Active Ingredient of MOTRIN® INFANTS’ DROPS
0.5 FL OZ (15 mL)
INGREDIENTS AND APPEARANCE
| IBUPROFEN
ibuprofen suspension |
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| Labeler - Major Pharmaceuticals (191427277) |