DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Ibuprofen (200 mg)

Inactive Ingredients

Ammonia Fd&c Green No. 3 Gelatin Ferrosoferric Oxide Medium-chain Triglycerides Polyethylene Glycol 400 Propylene Glycol Potassium Hydroxide Water Shellac Sorbitan Monooleate Sorbitol Sorbitan

Identifiers & Packaging

Pill Appearance

Imprint: 133 Shape: capsule Color: green Size: 19 mm Score: 1

Marketing Status

ANDA Active Since 2014-07-02

Medication Information

Purpose

Pain reliever/Fever reducer

Description

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (Present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug

Use(s)

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

Warnings

Allergy alert:

Ibuprofenmay 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 anallergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:

Thisproduct contains an NSAID, which may cause severe stomach bleeding. The chanceis 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

Directions

do not take more than directed
the smallest effective dose should be used
adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
if pain or fever does not respond to 1 capsule, 2 capsules may be used
do not exceed 6 capsules in 24 hours, unless directed by a doctor
children under 12 years: ask a doctor

Do Not Use

if you have ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery

Active Ingredient(s)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(Present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

Inactive Ingredient(s)

Ammonium hydroxide, FD&C green no.3, Gelatin, Iron oxide black (ferrosoferric oxide), Medium chain triglycerides, Polyethylene glycol, Propylene glycol, Potassium hydroxide, Purified water, Shellac, Sorbitol, Sorbitan monooleate

Other Required Warnings

each capsule contains: potassium 20 mg
read all warnings and directions before use. Keep carton.
store at 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F)

Pregnancy/breastfeeding

Ask a health professional before use. It is especiallyimportant not to use ibuprofen during the last 3 months of pregnancy unlessdefinitely directed to do so by a doctor because it may cause problems in theunborn child or complications during delivery.

Principal Display Panel

NDC 49035-133-12

equateTM

Ibuprofen

Capsules, 200mg

Pain Reliever/ Fever Reducer

(NSAID)

200mg, 20 SOFTGELS

Liquid-Filled Capsules

NDC 49035-133-14

equate^TM

Ibuprofen

Capsules, 200mg

Pain Reliever/ Fever

Reducer (NSAID)

Liquid-Filled Capsules

200mg, 40 SOFTGELS

NDC 49035-133-18

equate^TM

Ibuprofen

Capsules, 200mg

Pain Reliever/ Fever

Reducer (NSAID)

Liquid-Filled Capsules

200mg, 80 SOFTGELS

NDC 49035-133-26

equate^TM

Ibuprofen

Capsules, 200mg

Pain Reliever/ Fever

Reducer (NSAID)

Liquid-Filled Capsules

200mg, 160 SOFTGELS

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

Ask A Doctor Before Use If

the 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, or asthma
you are taking a diuretic

Stop Use and Ask 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
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

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)

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 other drug

Structured Label Content

Use(s) (USE(S))

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

Purpose (PURPOSE)

Pain reliever/Fever reducer

Warnings (WARNINGS)

Allergy alert:

Ibuprofenmay 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 anallergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:

Thisproduct contains an NSAID, which may cause severe stomach bleeding. The chanceis 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

Directions (DIRECTIONS)

do not take more than directed
the smallest effective dose should be used
adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
if pain or fever does not respond to 1 capsule, 2 capsules may be used
do not exceed 6 capsules in 24 hours, unless directed by a doctor
children under 12 years: ask a doctor

Do Not Use (DO NOT USE)

if you have ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(Present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

Inactive Ingredient(s) (INACTIVE INGREDIENT(S))

Ammonium hydroxide, FD&C green no.3, Gelatin, Iron oxide black (ferrosoferric oxide), Medium chain triglycerides, Polyethylene glycol, Propylene glycol, Potassium hydroxide, Purified water, Shellac, Sorbitol, Sorbitan monooleate

Other Required Warnings (OTHER REQUIRED WARNINGS)

each capsule contains: potassium 20 mg
read all warnings and directions before use. Keep carton.
store at 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F)

Pregnancy/breastfeeding (PREGNANCY/BREASTFEEDING)

Ask a health professional before use. It is especiallyimportant not to use ibuprofen during the last 3 months of pregnancy unlessdefinitely directed to do so by a doctor because it may cause problems in theunborn child or complications during delivery.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 49035-133-12

equateTM

Ibuprofen

Capsules, 200mg

Pain Reliever/ Fever Reducer

(NSAID)

200mg, 20 SOFTGELS

Liquid-Filled Capsules

NDC 49035-133-14

equate^TM

Ibuprofen

Capsules, 200mg

Pain Reliever/ Fever

Reducer (NSAID)

Liquid-Filled Capsules

200mg, 40 SOFTGELS

NDC 49035-133-18

equate^TM

Ibuprofen

Capsules, 200mg

Pain Reliever/ Fever

Reducer (NSAID)

Liquid-Filled Capsules

200mg, 80 SOFTGELS

NDC 49035-133-26

equate^TM

Ibuprofen

Capsules, 200mg

Pain Reliever/ Fever

Reducer (NSAID)

Liquid-Filled Capsules

200mg, 160 SOFTGELS

When Using This Product (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

Ask A Doctor Before Use If (ASK A DOCTOR BEFORE USE IF)

the 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, or asthma
you are taking a diuretic

Stop Use and Ask Doctor If (STOP USE AND ASK 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
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

Keep Out of Reach of Children (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)

Ask A Doctor Or Pharmacist Before Use If (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 other drug

Advanced Ingredient Data

[{"name": "IBUPROFEN", "unii": "WK2XYI10QM", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "AMMONIA", "unii": "5138Q19F1X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C GREEN NO. 3", "unii": "3P3ONR6O1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM HYDROXIDE", "unii": "WZH3C48M4T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHELLAC", "unii": "46N107B71O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN MONOOLEATE", "unii": "06XEA2VD56", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "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", "PURPOSE": "Pain reliever/Fever reducer", "WARNINGS": "Allergy alert: Ibuprofenmay 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 anallergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: Thisproduct contains an NSAID, which may cause severe stomach bleeding. The chanceis 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", "DIRECTIONS": "do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules in 24 hours, unless directed by a doctor children under 12 years: ask a doctor", "DO NOT USE": "if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery", "ACTIVE INGREDIENT(S)": "Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (Present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug", "INACTIVE INGREDIENT(S)": "Ammonium hydroxide, FD&C green no.3, Gelatin, Iron oxide black (ferrosoferric oxide), Medium chain triglycerides, Polyethylene glycol, Propylene glycol, Potassium hydroxide, Purified water, Shellac, Sorbitol, Sorbitan monooleate", "OTHER REQUIRED WARNINGS": "each capsule contains: potassium 20 mg read all warnings and directions before use. Keep carton. store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)", "PREGNANCY/BREASTFEEDING": "Ask a health professional before use. It is especiallyimportant not to use ibuprofen during the last 3 months of pregnancy unlessdefinitely directed to do so by a doctor because it may cause problems in theunborn child or complications during delivery.", "PRINCIPAL DISPLAY PANEL": "NDC 49035-133-12 equateTM Ibuprofen Capsules, 200mg Pain Reliever/ Fever Reducer (NSAID) 200mg, 20 SOFTGELS Liquid-Filled Capsules NDC 49035-133-14 equate TM Ibuprofen Capsules, 200mg Pain Reliever/ Fever Reducer (NSAID) Liquid-Filled Capsules 200mg, 40 SOFTGELS NDC 49035-133-18 equate TM Ibuprofen Capsules, 200mg Pain Reliever/ Fever Reducer (NSAID) Liquid-Filled Capsules 200mg, 80 SOFTGELS NDC 49035-133-26 equate TM Ibuprofen Capsules, 200mg Pain Reliever/ Fever Reducer (NSAID) Liquid-Filled Capsules 200mg, 160 SOFTGELS", "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", "ASK A DOCTOR BEFORE USE IF": "the 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, or asthma you are taking a diuretic", "STOP USE AND ASK 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 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", "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)", "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 other drug"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information