601r-dollar General - Ibuprofen Tablets 200 Mg 55910-901

601r-dollar General - Ibuprofen Tablets 200 Mg 55910-901
SPL v3
SPL
SPL Set ID 8f1358aa-495a-23da-e053-2995a90aa430
Route
ORAL
Published
Effective Date 2019-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Croscarmellose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Silicon Dioxide Ferric Oxide Red Magnesium Stearate Starch, Corn Talc Titanium Dioxide Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: 114 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2019-12-09
Description

Ibuprofen 200 mg (NSAID)* * nonstreoidal anti-inflammatory drug

Medication Information

Warnings and Precautions
WARNINGS

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

asthma (wheezing)

blisters

facial swelling

hives

rash

shock

skin reddening

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:

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 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

Heart attack and stroke warning: NSAID's except aspirin increases the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or longer than directed.

Indications and Usage

USE(S)

temporarily relieves minor aches and pains due to :

backache

headache

menstrual cramps

minor pain of arthritis

muscular aches

the common cold

toothache

temporarily reduces fever

Dosage and Administration

DIRECTIONS

do not take more than directed

the smallest effective dose should be used

adults and children 12 years and older:

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 used

do not exceed 6 tablets in 24 hours, unless directed by a doctor.

Children under 12 years:

ask a doctor

Description

Ibuprofen 200 mg (NSAID)* * nonstreoidal anti-inflammatory drug

Section 50565-1

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)

Section 51727-6

Silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide.

Section 51945-4

Section 55105-1

Pain reliever / fever reducer

Section 55106-9

Ibuprofen 200 mg (NSAID)*

* nonstreoidal anti-inflammatory drug

Structured Label Content

Indications and Usage (34067-9)

USE(S)

temporarily relieves minor aches and pains due to :

backache

headache

menstrual cramps

minor pain of arthritis

muscular aches

the common cold

toothache

temporarily reduces fever

Dosage and Administration (34068-7)

DIRECTIONS

do not take more than directed

the smallest effective dose should be used

adults and children 12 years and older:

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 used

do not exceed 6 tablets in 24 hours, unless directed by a doctor.

Children under 12 years:

ask a doctor

Warnings and Precautions (34071-1)
WARNINGS

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

asthma (wheezing)

blisters

facial swelling

hives

rash

shock

skin reddening

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:

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 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

Heart attack and stroke warning: NSAID's except aspirin increases the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or longer than directed.

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. (1-800-222-1222)

Section 51727-6 (51727-6)

Silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Pain reliever / fever reducer

Section 55106-9 (55106-9)

Ibuprofen 200 mg (NSAID)*

* nonstreoidal anti-inflammatory drug

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:27.868441 · Updated: 2026-03-14T23:00:54.830446