Search by Drug Name or NDC
NDC 67060-0001-67 IBUPROFEN 200 mg/1 Details
IBUPROFEN 200 mg/1
IBUPROFEN is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by ADVANCED FIRST AID, INC.. 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: 67060-0001-67Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ibuprofen
Product Information
NDC | 67060-0001 |
---|---|
Product ID | 67060-001_feb250d0-cddb-448d-b08d-00a0fc091055 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | IBUPROFEN |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | IBUPROFEN 200MG |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET, FILM COATED |
Route | ORAL |
Active Ingredient Strength | 200 |
Active Ingredient Units | mg/1 |
Substance Name | IBUPROFEN |
Labeler Name | ADVANCED FIRST AID, INC. |
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 | ANDA079174 |
Listing Certified Through | 2024-12-31 |
Package
Package Images


NDC 67060-0001-67 (67060000167)
NDC Package Code | 67060-001-67 |
---|---|
Billing NDC | 67060000167 |
Package | 250 PACKET in 1 CARTON (67060-001-67) / 2 TABLET, FILM COATED in 1 PACKET |
Marketing Start Date | 2015-04-09 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 564e9910-b491-4129-a4f1-68216267623b Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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 • blisters If an allergic reaction occurs, stop use and seek medical help right away.
Stomach Bleeding Warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others] • have 3 or more alcoholic drinks every day while using this product • take 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.
Do not use: • if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery
Ask a doctor use if you have: • problems or serious side effects from taking pain relievers or fever reducers • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain •
ulcers • bleeding problems • high blood pressure • heart disease, liver cirrhosis, or kidney disease • taken a diuretic • reached age 60 or older
Ask a doctor or pharmacist before use if you are: • taking any other drug containing an NSAID (prescription or nonprescription) • taking a blood thinning (anticoagulant) or steroid drug • under a doctor’s care for any serious condition • taking any other drug
taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
When using this product: • take with food or milk if stomach upset occurs • long term continuous use may increase the risk of heart attack or stroke
Stop use and ask a doctor if: • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • stomach pain or upset gets worse or lasts • redness or swelling is present in the painful area • any new symptoms appear
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions:
Adults and children 12 years of age and older:
• do not take more than directed • the smallest effective dose should be used • take 1 tablet every 4 to 6 hours while symptoms
persist. • If pain or fever does not respond to 1 tablet, 2 tablets may be used • do not exceed 6 tablets in 24 hours, unless directed by a doctor.
Children under 12 years of age: do not use for children under 12 years of age unless directed by a doctor.
SPL UNCLASSIFIED SECTION
Inactive Ingredients: crosscarmellose sodium*, FD& C Blue #2*, FD& C red #40*, FD& C Yellow #6*, hypromellose*, iron oxide red*, lactose monohydrate*, magnesium stearate*, maltodextrin*, medium chain triglycerides*, microcrystalline cellulose*, polydextrose*, polyethylene glycol*, polyvinyl alcohol*, povidone (K-30)*, silicon dioxide, sodium starch glycolate*, starch, stearic acid*, talc*, titanium dioxide, triacetin* *contains one or more of these ingredients
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen 200mg tablet, film coated |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
Labeler - ADVANCED FIRST AID, INC. (114477180) |
Registrant - ADVANCED FIRST AID, INC. (114477180) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
ULTRA SEAL CORPORATION | 085752004 | pack(67060-001) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
GRANULES INDIA LTD | 918609236 | manufacture(67060-001) |