RxNorm Names
Review RxNorm Normal Forms
IBUPROFEN capsule, coated
[Safeway]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=45520969-7a2d-4469-ba25-7db160d50ccf| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | Abbreviated New Drug Application |
Active ingredient (in each orange caplet)
Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Uses
- temporarily relieves minor aches and pains due to:
- headache
- toothecahe
- backache
- menstrual cramps
- the common cold
- muscular aches
- minor pain of arthritis
- temporarily reduces fever
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:
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- have 3 or more alcoholic drinnks every day while using this product
- take more or for a longer time 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 before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have asthma
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if
- 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 of drug
When using this product
- take with food or milk if stomach upset occurs
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- 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
Directions
- do not take more than directed
- the smallest effective dose should be used
- adults and children 12 years and over: take 1 caplet every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 caplet, 2 caplets may be used
- do not exceed 6 caplets in 24 hours, unless directed by a doctor
- children under 12 years: ask a doctor
Other information
- store between 20º-25ºC (68º-77ºF)
- avoid excess heat 40ºC (104ºF)
- see end flap for expiration date and lot number
Inactive ingredients
carnauba wax, cellulose, corn starch, FD&C yellow #6 aluminum lake, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide
Principal Display Panel
NDC 21130-291-08
Compare to Motrin® IB active ingredient†
Ibuprofen
ibuprofen Tablets USP, 200 mg
• Pain Reliever / Fever Reducer
(NSAID)
SEE NEW WARNINGS INFORMATION
100 CAPLETS** **Capsule-shaped tablets
SAFEWAY™
†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Motrin® IB.
50844 REV0411C39312
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Safeway 44-393
| IBUPROFEN
ibuprofen capsule, coated |
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| Labeler - Safeway (009137209) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| LNK International, Inc. | 038154464 | PACK(21130-393) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| LNK International, Inc. | 832867894 | MANUFACTURE(21130-393) | |
