Ibuprofen Tablets USP 200 mg

Set ID
119263b5-c3b7-46dc-a3bd-9893bfd24628
Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-10
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:41:48

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each caplet)

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

Purpose

Pain reliever/fever reducer

Uses

Uses

temporarily relieves minor aches and pain due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever

Warnings

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 a nonsteroidal anti-inflammatory drug (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 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

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

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, asthma or had a stroke ¬ you are taking a diuretic

Ask a doctor or pharmacist before use if you are

¬ 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

Directions And Dosage

Directions

¬ do not take more than directed ¬ the smallest effective dose should be used ¬ do not take longer than 10 days, unless directed by a doctor (see Warnings) ¬ 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 Label Information

Inactive ingredients

colloidal silicon dioxide, FD&C yellow no. 6, maize starch, polyethylene glycol, polyvinyl alcohol, povidone k30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide.

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

Ibuprofen Ibuprofen Tablets 200 mg - Pain reliever/fever reducer (NSAID)

Products

NDC Codes

Ingredients

NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
STARCH, CORNO8232NY3SJIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE K30U725QWY32XIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
IBUPROFENWK2XYI10QMACTIB

Complete SPL Sections

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pain due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever

Warnings

WARNINGS 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 a nonsteroidal anti-inflammatory drug (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 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

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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 for longer than directed.

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

¬ 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, asthma or had a stroke ¬ you are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

¬ 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

When using this product

OTC - WHEN USING SECTION

¬ 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

OTC - STOP USE SECTION

¬ 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 ¬ you have symptoms of heart problems or stroke:

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

OTC - STOP USE SECTION

OTC - STOP USE SECTION

¬ chest pain ¬ trouble breathing ¬ leg swelling ¬ slurred speech ¬ weakness in one part or side of body ¬ 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

¬ do not take more than directed ¬ the smallest effective dose should be used ¬ do not take longer than 10 days, unless directed by a doctor (see Warnings) ¬ 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

OTHER SAFETY INFORMATION

¬ read all warnings and directions before use. ¬ store between 20°-25°C (68°-77°F) ¬ avoid excessive heat above 40°C (104°F)

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, FD&C yellow no. 6, maize starch, polyethylene glycol, polyvinyl alcohol, povidone k30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ibuprofen Ibuprofen Tablets 200 mg - Pain reliever/fever reducer (NSAID)

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

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