Label: IBUPROFEN tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 61919-123-30 - Packager: DIRECT RX
- This is a repackaged label.
- Source NDC Code(s): 0904-7915
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 3, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- OTC - ACTIVE INGREDIENT SECTION
- OTC - PURPOSE SECTION
- INDICATIONS & USAGE SECTION
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WARNINGS SECTION
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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hives
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facial swelling
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asthma (wheezing)
-
shock
-
skin reddening
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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:
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have had stomach ulcers or bleeding problems
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take a blood thinning (anticoagulant) or steroid drug
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take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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have 3 or more alcoholic drinks every day while using this product
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take more or for a longer time than directed
Do not use
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right before or after heart surgery
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if you have ever had an allergic reaction to any other pain reliever/fever reducer
Ask a doctor before use if you have
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stomach bleeding warning applies to you
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you have a history of stomach problems, such as heartburn
-
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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you are taking a diuretic
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you have asthma
-
you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are
- taking any other drug
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- under a doctor"s care for any serious condition
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
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
-
-
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
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
Do not use
right before or after heart surgery
if you have ever had an allergic reaction to any other pain reliever/fever reducer
Ask a doctor before use if you have
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, or kidney disease
you are taking a diuretic
you have asthma
you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are
taking any other drug
taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
under a doctor"s care for any serious conditionWhen 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
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
-
OTC - WHEN USING SECTION
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do not take more than directed
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the smallest effective dose should be used
- adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
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if pain or fever does not respond to 1 tablet, 2 tablets may be used
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do not exceed 6 tablets in 24 hours, unless directed by a doctor
-
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children under 12 years: ask a doctor
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- INFORMATION FOR PATIENTS SECTION
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DOSAGE & ADMINISTRATION SECTION
do not take more than directedthe smallest effective dose should be used
adults and children 12 years and over: 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 useddo not exceed 6 tablets in 24 hours, unless directed by a doctor
children under 12 years: ask a doctor
- INACTIVE INGREDIENT SECTION
- OTC - QUESTIONS SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61919-123(NDC:0904-7915) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;291 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-123-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/01/2014 Labeler - DIRECT RX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 relabel(61919-123) , repack(61919-123)
