c01538b0-ca4c-434a-be8f-fe023deb84e1
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Uses: temporarily relieves minor aches and pains due to:•headache • minor pain of arthritis • the common cold • toothache • backache • menstrual cramps • muscular aches • temporarily reduces fever
Medication Information
Warnings and Precautions
Warnings:
Allergy Alert: Ibuprofen may cause a severe allergic
reaction which may include:
• hives • shock • facial swelling • asthma (wheezing)
Alcohol Warning: If you consume 3 or more alcoholic
drinks every day, ask your doctor whether you should
take Ibuprofen or other pain relievers/ fever reducers.
Ibuprofen may cause stomach bleeding.
Do not use:
• if you have ever had an allergic reaction to any
other pain reliever/fever reducer
Ask a doctor before use if you have:
• stomach pain
• problems or serious side eects from taking
pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are:
• under a doctor's care for any serious condition
• taking any other drug
• taking any other product that contains Ibuprofen,
or any other pain reliever/fever reducer
When using this product give with food or milk if
stomach upset occurs.
Stop use and ask a doctor if:
• an allergic reaction occurs. Seek medical help right
away • pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• stomach pain or upset gets worse or lasts
• any new symptoms appear • redness or swelling is
present in the painful area
Indications and Usage
Uses: temporarily relieves minor aches and pains due to:•headache • minor pain of arthritis • the common cold • toothache • backache • menstrual cramps • muscular aches • temporarily reduces fever
Dosage and Administration
Directions:
• Do not take more than directed.
Adults and children 12 years and older
• Take 1 tablet every 4 to 6 hours while symptoms
• If pain or fever does not respond to 1 tablet, 2 tablets may be used.
Do not exceed 6 tablets in 24 hours, unless as directed by a doctor.
• The smallest effective dose should be used.
Children under 12 year
• Ask a doctor.
Description
Uses: temporarily relieves minor aches and pains due to:•headache • minor pain of arthritis • the common cold • toothache • backache • menstrual cramps • muscular aches • temporarily reduces fever
Section 50565-1
KEEP OUT OF REACH OF CHILDREN. In
case of overdose, get medical help or
contact a Poison Control Center right
away.
Section 51727-6
Inactive Ingredients:
carnauba wax, croscarmellose sodium,
hydroxypropyl methylcellulose,
microcrystalline cellulose,
polyethylene glycol, polysorbate 80,
povidone, pregelatinized starch, silicon
dioxide, sodium starch glycolate,
stearic acid and titanium dioxide.
Section 51945-4
Section 53414-9
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 directed to do so by a doctor because it may
cause problems in the unborn
child or complications during delivery.
Section 55105-1
PAIN RELIEVER/FEVER REDUCER
Section 55106-9
ACTIVE INGREDIENT-IBUPROFEN 200 MG
Structured Label Content
Indications and Usage (34067-9)
Uses: temporarily relieves minor aches and pains due to:•headache • minor pain of arthritis • the common cold • toothache • backache • menstrual cramps • muscular aches • temporarily reduces fever
Dosage and Administration (34068-7)
Directions:
• Do not take more than directed.
Adults and children 12 years and older
• Take 1 tablet every 4 to 6 hours while symptoms
• If pain or fever does not respond to 1 tablet, 2 tablets may be used.
Do not exceed 6 tablets in 24 hours, unless as directed by a doctor.
• The smallest effective dose should be used.
Children under 12 year
• Ask a doctor.
Warnings and Precautions (34071-1)
Warnings:
Allergy Alert: Ibuprofen may cause a severe allergic
reaction which may include:
• hives • shock • facial swelling • asthma (wheezing)
Alcohol Warning: If you consume 3 or more alcoholic
drinks every day, ask your doctor whether you should
take Ibuprofen or other pain relievers/ fever reducers.
Ibuprofen may cause stomach bleeding.
Do not use:
• if you have ever had an allergic reaction to any
other pain reliever/fever reducer
Ask a doctor before use if you have:
• stomach pain
• problems or serious side eects from taking
pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are:
• under a doctor's care for any serious condition
• taking any other drug
• taking any other product that contains Ibuprofen,
or any other pain reliever/fever reducer
When using this product give with food or milk if
stomach upset occurs.
Stop use and ask a doctor if:
• an allergic reaction occurs. Seek medical help right
away • pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• stomach pain or upset gets worse or lasts
• any new symptoms appear • redness or swelling is
present in the painful area
Section 50565-1 (50565-1)
KEEP OUT OF REACH OF CHILDREN. In
case of overdose, get medical help or
contact a Poison Control Center right
away.
Section 51727-6 (51727-6)
Inactive Ingredients:
carnauba wax, croscarmellose sodium,
hydroxypropyl methylcellulose,
microcrystalline cellulose,
polyethylene glycol, polysorbate 80,
povidone, pregelatinized starch, silicon
dioxide, sodium starch glycolate,
stearic acid and titanium dioxide.
Section 51945-4 (51945-4)
Section 53414-9 (53414-9)
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 directed to do so by a doctor because it may
cause problems in the unborn
child or complications during delivery.
Section 55105-1 (55105-1)
PAIN RELIEVER/FEVER REDUCER
Section 55106-9 (55106-9)
ACTIVE INGREDIENT-IBUPROFEN 200 MG
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:00:27.932808 · Updated: 2026-03-14T23:00:54.830446