Ibuprofen Capsules, Liquid Filled, 200 Mg

Ibuprofen Capsules, Liquid Filled, 200 Mg
SPL v13
SPL
SPL Set ID 5f27dd3f-c735-417b-95e6-26dc5aae5a7a
Route
ORAL
Published
Effective Date 2024-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Blue No. 1 Gelatin Polyethylene Glycol, Unspecified Water Potassium Hydroxide Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: A;77 Shape: capsule Color: turquoise Size: 18 mm Score: 1
Marketing Status
ANDA Active Since 2011-12-23

Description

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

Indications and Usage

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

Dosage and Administration

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


Medication Information

Warnings and Precautions

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
Indications and Usage
  • 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

Dosage and Administration

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
Description

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

Otc Purpose

Pain reliever/Fever reducer

Otc Stop Use

Stop use and ask a doctor if

  • you experience any of the follwing signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • 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 Ask Doctor

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, or asthma
  • you are taking a diuretic
Otc 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
Otc When Using

When using this product

  • take with food or milk if upset stomach occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Other Information
  • each capsule contains: potassium 20 mg
  • read all warnings and directions before use.  Keep carton.
  • Store at 20º to 25ºC (68º to 77ºF)
  • avoid excessive heat above 40ºC (104ºF)
Inactive Ingredients

D&C Yellow # 10, FD&C Blue # 1, gelatin, polyethylene glycol, potassium hydroxide, purified water, sorbitol

Otc 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

Otc Ask Doctor/pharmacist

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
Otc – Questions Or Comments?

Call 1-877-835-5472 Monday through Friday 9AM - 5PM EST

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

Do Not Use if printed foil under cap is broken or missing.

Distributed by:  Amneal Pharmaceuticals

Glasgow, KY  42141

Rev. 08-2011

Otc Pregnancy Or Breast Feeding

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.

Otc 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 (1-800-222-1222) right away.

Package Label.principal Display Panel


Structured Label Content

Warnings and Precautions (34071-1)

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
Otc Purpose (OTC - PURPOSE)

Pain reliever/Fever reducer

Otc Stop Use (OTC - STOP USE)

Stop use and ask a doctor if

  • you experience any of the follwing signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • 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 Ask Doctor (OTC - ASK DOCTOR)

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, or asthma
  • you are taking a diuretic
Otc Do Not Use (OTC - 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
Otc When Using (OTC - WHEN USING)

When using this product

  • take with food or milk if upset stomach occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Other Information (OTHER INFORMATION)
  • each capsule contains: potassium 20 mg
  • read all warnings and directions before use.  Keep carton.
  • Store at 20º to 25ºC (68º to 77ºF)
  • avoid excessive heat above 40ºC (104ºF)
Inactive Ingredients (INACTIVE INGREDIENTS)

D&C Yellow # 10, FD&C Blue # 1, gelatin, polyethylene glycol, potassium hydroxide, purified water, sorbitol

Indications and Usage (INDICATIONS AND USAGE)
  • 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
Otc Active Ingredient (OTC - 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

Dosage and Administration (DOSAGE AND ADMINISTRATION)

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
Otc Ask Doctor/pharmacist (OTC - ASK DOCTOR/PHARMACIST)

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
Otc – Questions Or Comments? (OTC – QUESTIONS OR COMMENTS?)

Call 1-877-835-5472 Monday through Friday 9AM - 5PM EST

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

Do Not Use if printed foil under cap is broken or missing.

Distributed by:  Amneal Pharmaceuticals

Glasgow, KY  42141

Rev. 08-2011

Otc Pregnancy Or Breast Feeding (OTC - PREGNANCY OR BREAST FEEDING)

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.

Otc Keep Out of Reach of Children (OTC - 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 (1-800-222-1222) right away.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


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