Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID 3802982a-2373-9ca3-e063-6394a90a0ab7

Route

ORAL

Published

Effective Date 2025-09-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Ibuprofen (200 mg)

Inactive Ingredients

Fd&c Blue No. 1 Gelatin Polyethylene Glycol, Unspecified Potassium Hydroxide Water Sorbitan Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: IB1 Shape: capsule Color: blue Size: 20 mm Score: 1

Marketing Status

ANDA Active Since 2025-06-20

Description

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

Purpose

Pain reliever/Fever reducer

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

Uses

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: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

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

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

48's Carton

NDC 83324-206-48

QC _®

QUALITY CHOICE

^† Compare to the

Active Ingredient in

Advil ^® LIQUI-GELS ^®

Ibuprofen

Ibuprofen Capsules, 200 mg

Pain Reliever/Fever Reducer (NSAID)

20%

FREE

actual size

48Softgels**

**Liquid Filled Capsules

Other Information

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

Inactive Ingredients

FD&C Blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol

For India Manufacturing Site:

FD&C Blue #1, gelatin, polyethylene glycol,potassium hydroxide, purified water, sorbitan and sorbitol

Questions Or Comments?

call toll free 1-888-235-2466

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

^†All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Advil ^®LIQUI-GELS ^®.

Distributed by C.D.M.A., Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

L0000925

R1024

For India Manufacturing Site:

MADE IN INDIA

Code: TN/DRUGS/TN/25/00074

P3457/00/25

R0325 L0001019

When Using This Product

take with food or milk if stomach upset occurs

Ask A Doctor Before Use If

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

Stop Use and Ask A 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
you have symptoms of heart problems or stroke:
chest pain
trouble breathing
weakness in one part or side of body
slurred speech
leg swelling
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.

48's Carton Made in India Label

NDC 83324-206-48

QC ®

QUALITY CHOICE

† Compare to the

Active Ingredient in

Advil ® LIQUI-GELS ®

Ibuprofen

Capsules, 200 mg

Pain Reliever/Fever Reducer (NSAID)

20%

FREE

actual size

48 Softgels**

**Liquid Filled Capsules

If Pregnant Or Breast Feeding,

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause delivery problems in the unborn child or complications during delivery.

Active Ingredient (in Each Capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

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

Structured Label Content

Uses

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: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

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 (Do not use)

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

48's Carton (48's carton)

NDC 83324-206-48

QC _®

QUALITY CHOICE

^† Compare to the

Active Ingredient in

Advil ^® LIQUI-GELS ^®

Ibuprofen

Ibuprofen Capsules, 200 mg

Pain Reliever/Fever Reducer (NSAID)

20%

FREE

actual size

48Softgels**

**Liquid Filled Capsules

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

FD&C Blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol

For India Manufacturing Site:

FD&C Blue #1, gelatin, polyethylene glycol,potassium hydroxide, purified water, sorbitan and sorbitol

Questions Or Comments? (Questions or comments?)

call toll free 1-888-235-2466

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

^†All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Advil ^®LIQUI-GELS ^®.

Distributed by C.D.M.A., Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

L0000925

R1024

For India Manufacturing Site:

MADE IN INDIA

Code: TN/DRUGS/TN/25/00074

P3457/00/25

R0325 L0001019

When Using This Product (When using this product)

take with food or milk if stomach upset occurs

Ask A Doctor Before Use If (Ask a doctor before use if)

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

Stop Use and Ask A Doctor If (Stop use and ask a 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
you have symptoms of heart problems or stroke:
chest pain
trouble breathing
weakness in one part or side of body
slurred speech
leg swelling
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.

48's Carton Made in India Label (48's carton-Made In India label)

NDC 83324-206-48

QC ®

QUALITY CHOICE

† Compare to the

Active Ingredient in

Advil ® LIQUI-GELS ®

Ibuprofen

Capsules, 200 mg

Pain Reliever/Fever Reducer (NSAID)

20%

FREE

actual size

48 Softgels**

**Liquid Filled Capsules

If Pregnant Or Breast Feeding, (If pregnant or breast- feeding,)

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (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

Advanced Ingredient Data

[{"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "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": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IBUPROFEN", "unii": "WK2XYI10QM", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "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: 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 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 Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be be fatal. The risk is higher if you use more than directed or for longer 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", "48's carton": "NDC 83324-206-48 QC ® QUALITY CHOICE † Compare to the Active Ingredient in Advil ® LIQUI-GELS ® Ibuprofen Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) 20% More FREE actual size 48 Softgels** **Liquid Filled Capsules", "Other information": "each capsule contains: potassium 20 mg read all warnings and directions before use. Keep carton. store at 20° to 25°C (68° to 77°F) avoid excessive heat above 40°C (104°F). Protect from light. ", "Inactive ingredients": "FD&C Blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol For India Manufacturing Site: FD&C Blue #1, gelatin, polyethylene glycol,potassium hydroxide, purified water, sorbitan and sorbitol", "Questions or comments?": "call toll free 1-888-235-2466 DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION ” IS BROKEN OR MISSING. READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION † All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Advil ® LIQUI-GELS ® . Distributed by C.D.M.A., Inc. Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 L0000925 R1024 For India Manufacturing Site: MADE IN INDIA Code: TN/DRUGS/TN/25/00074 P3457/00/25 R0325 L0001019", "When using this product": "take with food or milk if stomach upset occurs", "Ask a doctor before use if": "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", "Stop use and ask a 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 you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling 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.", "48's carton-Made In India label": "NDC 83324-206-48 QC ® QUALITY CHOICE † Compare to the Active Ingredient in Advil ® LIQUI-GELS ® Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) 20% More FREE actual size 48 Softgels** **Liquid Filled Capsules", "If pregnant or breast- feeding,": "ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause delivery problems in the unborn child or complications during delivery.", "Active ingredient (in each capsule)": "Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug", "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"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:58.307639 · Updated: 2026-03-14T23:10:05.459246