Label: IBUPROFEN tablet
- NDC Code(s): 55319-366-25
- Packager: Family Dollar
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 10, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
Active ingredient (in each caplet)
Ibuprofen 200 mg (NSAID)*
-
Purposes
Pain reliever/ fever reducer
-
Uses
■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ minor pain of arthritis - ■ toothache ■ backache ■ the common cold - ■ menstrual cramps - ■ temporarily ...
-
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 ...
-
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 ...
-
Do not use
■ if you have 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
■ 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 ...
-
Ask a doctor or pharmacist before use if you are
■ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin - ■ under a doctor’s care for any serious condition - ■ taking any other drug
-
When using this product
■ take with food or milk if stomach upset occurs
-
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 ...
-
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 ...
-
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
-
Directions
■ do not take more than directed - ■ the smallest effective dose should be used - adults and children 12 years and older ■ take 1 caplet every 4 to 6 hours while symptoms persist - ■ if pain ...
-
Other information
■ store between 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature] ■ avoid excessive heat above 40°C (104°F)
-
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
-
Questions or comments?
call - 1-877-770-3183 weekdays 8:00 AM EST to 5:00 PM PST
-
PDP
-
INGREDIENTS AND APPEARANCEProduct Information