pain relief

Manufacturer
Praxis, LLC
Effective date
2023-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:37:08

Label at a glance#

Productpain relief
Active ingredientIBUPROFEN
Label structure17 sections

Indications and 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

Dosage and administration

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

Storage and handling

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.

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Uses

INDICATIONS & USAGE SECTION

  • 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

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 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.

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • 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

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:
  • 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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

STORAGE AND HANDLING SECTION

  • 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 INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

call toll free 1-888-235-2466

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

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

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

Manufactured for:

BIONPHARMA

Princeton, NJ 08540

R0223

L0000705

For India Manufacturing Site:

Manufactured for:

Bionpharma Inc.

Princeton, NJ 08540

MADE IN INDIA

Code: TN/DRUGS/TN/25/00074

R0125

L0000939

P3238/01/24

300's count label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†compare tothe active ingredient in Advil®Liqui-Gels®

NDC 69452-260-

a+health

pain relief

ibuprofen capsules,

200 mg (NSAID)

pain reliever/fever reducer

300softgels**

**liquid filled capsules

frontfront

backback

300's count label-Made In India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

† compare tothe active ingredient in Advil ® Liqui-Gels ®

NDC 69452-260-83

a+health

pain relief

ibuprofen capsules,

200 mg

pain reliever/fever reducer

(NSAID)

300 softgels**

**liquid filled capsules

(MADE IN INDIA)

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Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59368-39659368-396-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
36e94de5-a18d-d65e-e063-6394a90aba6a36e95cc2-3c00-9a02-e063-6294a90a620e2023-01-01WarningsExact identifier
spl id: 36e94de5-a18d-d65e-e063-6394a90aba6a
spl set id: 36e95cc2-3c00-9a02-e063-6294a90a620e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.