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NDC 69822-0693-50 Ibuprofen 200mg 200 mg/1 Details
Ibuprofen 200mg 200 mg/1
Ibuprofen 200mg is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Southern Sales & Services, Inc.. The primary component is IBUPROFEN.
Product Information
NDC | 69822-0693 |
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Product ID | 69822-693_ec578861-5a51-5362-e053-2995a90ab54a |
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 200mg |
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 | Southern Sales & Services, 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 | ANDA072096 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 69822-0693-50 (69822069350)
NDC Package Code | 69822-693-50 |
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Billing NDC | 69822069350 |
Package | 50 TABLET, FILM COATED in 1 BOTTLE (69822-693-50) |
Marketing Start Date | 2022-10-31 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ec578861-5a50-5362-e053-2995a90ab54a Details
Directions
- do not take more than directed
- the smallest effective dose should be used
Adults and children 12 years and older:
- 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: ask a doctor
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 chances are 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 prescription or nonprescription NSAIDs [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
Inactive ingredients
Uses
Keep out of reach of children.
Don not use
Ask a doctor before use if
- you have problems or serious side effects from taking pain relievers or fever reducers
- the stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
Stop use and ask a doctor if
you experience any of the following signs of stomach bleeding:
- feel faint
- vomitblood
- have bloody or black stools
- have stomach pain that does not get better
- you have symptoms of heart problems or stroke: chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
If pregnant or breast-feeding
Other information
INGREDIENTS AND APPEARANCE
IBUPROFEN 200MG
ibuprofen 200mg tablet, film coated |
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Labeler - Southern Sales & Services, Inc. (013114906) |
Revised: 10/2022
Document Id: ec578861-5a51-5362-e053-2995a90ab54a
Set id: ec578861-5a50-5362-e053-2995a90ab54a
Version: 1
Effective Time: 20221031