Ibuprofen
Ibuprofen Caplets, 200 mg
34440532-03e1-4feb-b3e2-dab869edeb15
HUMAN OTC DRUG LABEL
Feb 1, 2025
BI-MART
DUNS: 027630078
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (10)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC37835-585-25
Compare to the active ingredient in Advil ®Caplets*
IBUPROFEN CAPLETS, 200 mg
- Pain Reliever
- Fever Reducer (NSAID)
250 Caplets
*This product is not manufactured or distributed by owner of the registered trademark Advil ®Caplets.
Distributed by
**BI-MART,**Eugene, OR 97402
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves minor aches and pains due to:
- headache
- toothache
- backache
- menstrual cramps
- the common cold
- muscular aches
- minor pain of arthritis
- temporarily reduces fever
SPL UNCLASSIFIED SECTION
Other Information
- store between 20°-25°C (68°-77°F)
- avoid excessive heat above 40°C (104°F)
- DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient (in each caplet)
Ibuprofen 200 mg (NSAID)******
**nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
PURPOSE
Pain reliever/ Fever reducer
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- under a doctor’s care for any serious condition
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- taking any other drug
OTC - WHEN USING SECTION
When using this product
- take with food or milk if stomach upset occurs
WARNINGS 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
- 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 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
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.
OTC - DO NOT USE SECTION
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
OTC - ASK DOCTOR SECTION
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have problems or serious side effects from taking pain relievers or fever reducers
- 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
OTC - STOP USE SECTION
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- 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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast feeding,
ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
DOSAGE & ADMINISTRATION SECTION
Directions
*do not take more than directed *the smallest effective dose should be used
adults and children 12 years and over |
|
children under 12 years |
|
INACTIVE INGREDIENT SECTION
Inactive ingredients
colloidal silicon dioxide, iron oxide red, maize starch, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide
OTC - QUESTIONS SECTION
Questions?
Call toll-free1-844-912-4012: