Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 1662a495-4f6a-4515-a405-557681e1a496
Route
ORAL
Published
Effective Date 2023-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Carnauba Wax Croscarmellose Sodium Fd&c Yellow No. 6 Aluminum Oxide Hypromelloses Cellulose, Microcrystalline Polydextrose Polyethylene Glycol, Unspecified Starch, Corn Silicon Dioxide Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 52 Shape: round Color: orange Size: 9 mm Score: 1
Marketing Status
ANDA Active Since 2013-08-01

Description

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

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

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

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps
  • 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
  • rash
  • blisters
  • skin reddening

If an allergic reaction occurs, stop use an seek medical help right away.

Stomach bleeding warning: This product contains an NSAID which may cause sever 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 non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • take more or for a longer time than directed
  • have 3 or more alcoholic drinks every day while using this product
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
Do Not Use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Product Label
Ibuprofen 200 mg tablets
Ibuprofen 200 mg tablets
Ibuprofen 200 mg orange tablet
Ibuprofen 200 mg orange tablet
Other Information
  • store between 20º-25ºC (68º-77ºF)
Inactive Ingredients

carnauba wax, croscarmellose sodium, FD&C yellow# 6 aluminium lake, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal Display Panel

Ibuprofen

Tablets USP, 200 mg

Pain Reliever/ Fever Reducer (NSAID)

Coated Tablets

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Manufactured by: Avema Pharma Solution

10400 NW 29th terrace

Miami, FL 33172

When Using This Product
  • 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
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, or kidney disease
  • you have asthma
  • you are taking a diuretic
Stop Use and Ask A Doctor If
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • have bloody or black stools  
    • vomit blood
    • have stomach pain that does not get better
  • pain gets worse or last more than 10 days
  • fever gets worse or last more than 3 days
  • redness or swelling is present the painful area
  • any new symptoms appear
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.

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).

Active Ingredient (in Each Tablet)

Ibuprofen USP, 200 mg (NSAID)*

*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
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps
  • 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
  • rash
  • blisters
  • skin reddening

If an allergic reaction occurs, stop use an seek medical help right away.

Stomach bleeding warning: This product contains an NSAID which may cause sever 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 non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • take more or for a longer time than directed
  • have 3 or more alcoholic drinks every day while using this product
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
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
Product Label
Ibuprofen 200 mg tablets
Ibuprofen 200 mg tablets
Ibuprofen 200 mg orange tablet
Ibuprofen 200 mg orange tablet
Other Information (Other information)
  • store between 20º-25ºC (68º-77ºF)
Inactive Ingredients (Inactive ingredients)

carnauba wax, croscarmellose sodium, FD&C yellow# 6 aluminium lake, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal Display Panel

Ibuprofen

Tablets USP, 200 mg

Pain Reliever/ Fever Reducer (NSAID)

Coated Tablets

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Manufactured by: Avema Pharma Solution

10400 NW 29th terrace

Miami, FL 33172

When Using This Product (When using this product)
  • 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
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, or kidney disease
  • you have asthma
  • 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
    • have bloody or black stools  
    • vomit blood
    • have stomach pain that does not get better
  • pain gets worse or last more than 10 days
  • fever gets worse or last more than 3 days
  • redness or swelling is present the painful area
  • any new symptoms appear
If Pregnant 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.

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 (1-800-222-1222).

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Ibuprofen USP, 200 mg (NSAID)*

*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


Raw Label Data

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