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NDC 71205-0425-24 JUNIOR STRENGTH ADVIL 100 mg/1 Details
JUNIOR STRENGTH ADVIL 100 mg/1
JUNIOR STRENGTH ADVIL is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. 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: 71205-0425-24Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ibuprofen
Product Information
| NDC | 71205-0425 |
|---|---|
| Product ID | 71205-425_91fc4794-1880-460f-86dd-49d8c1e872bc |
| Associated GPIs | |
| GCN Sequence Number | 022530 |
| GCN Sequence Number Description | ibuprofen TAB CHEW 100 MG ORAL |
| HIC3 | S2B |
| HIC3 Description | NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS |
| GCN | 35749 |
| HICL Sequence Number | 003723 |
| HICL Sequence Number Description | IBUPROFEN |
| Brand/Generic | Generic |
| Proprietary Name | JUNIOR STRENGTH ADVIL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ibuprofen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, CHEWABLE |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | IBUPROFEN |
| Labeler Name | Proficient Rx LP |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA020944 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 71205-0425-24 (71205042524)
| NDC Package Code | 71205-425-24 |
|---|---|
| Billing NDC | 71205042524 |
| Package | 1 BOTTLE in 1 CARTON (71205-425-24) / 24 TABLET, CHEWABLE in 1 BOTTLE |
| Marketing Start Date | 2020-03-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 91fc4794-1880-460f-86dd-49d8c1e872bc Details
USES
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
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
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- if the child has ever had an allergic reaction to any other pain reliever/fever reducer
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- right before or after heart surgery
Ask a doctor before use if
- •
- stomach bleeding warning applies to the child
- •
- child has problems or serious side effects from taking pain relievers or fever reducers
- •
- child has a history of stomach problems, such as heartburn
- •
- child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
- •
- child has not been drinking fluids
- •
- child has lost a lot of fluid due to vomiting or diarrhea
- •
- 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
- •
- 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
- •
- 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
DIRECTIONS
- •
- this product does not contain directions or complete warnings for adult use
- •
- do not give more than directed
- •
- find right dose on chart. If possible, use weight to dose; otherwise use age.
- •
- repeat dose every 6-8 hours, if needed
- •
- do not use more than 4 times a day
| Weight (lb) | Age (yr) | Dose (tablets) |
|---|---|---|
|
under 24 lb |
under 2 yr |
ask a doctor |
|
24-35 lb |
2-3 yr |
1 tablet |
|
36-47 lb |
4-5 yr |
1 ½ tablets |
|
48-59 lb |
6-8 yr |
2 tablets |
|
60-71 lb |
9-10 yr |
2 ½ tablets |
|
72-95 lb |
11 yr |
3 tablets |
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label
INGREDIENTS AND APPEARANCE
| JUNIOR STRENGTH ADVIL
ibuprofen tablet, chewable |
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| Labeler - Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Proficient Rx LP | 079196022 | REPACK(71205-425) , RELABEL(71205-425) | |