Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID c6dcc329-bab5-41ab-94e7-625e07628fd6
Route
ORAL
Published
Effective Date 2025-01-28
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: 55 Shape: capsule Color: orange Size: 14 mm Score: 1
Marketing Status
ANDA Completed Since 2013-08-01 Until 2025-02-02

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 severe stomach bleeding. The chance is higher if you:

  • are age 60 or oder
  • have had stomach ulcers or bleeding problems
  • take blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescritpion 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 prdouct
Directions
  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and older:
    • 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
Do Not Use
  • if you ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Product Label

Ibuprofen 200 mg orange Caplets
Ibuprofen 200 mg orange Caplets
Ibuprofen 200 mg orange Caplets
Ibuprofen 200 mg orange Caplets

Other Information
  • store between 20o- 25o C (68o- 77o F)
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 Caplets**

**(Capsule-Shaped Tablets)

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING

Manufactured by: Avema Pharma Solutions

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 in 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 druing the last 3 months of pegnancy unless defintely 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 Caplet)

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 severe stomach bleeding. The chance is higher if you:

  • are age 60 or oder
  • have had stomach ulcers or bleeding problems
  • take blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescritpion 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 prdouct
Directions
  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and older:
    • 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
Do Not Use (Do not use)
  • if you ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Product Label

Ibuprofen 200 mg orange Caplets
Ibuprofen 200 mg orange Caplets
Ibuprofen 200 mg orange Caplets
Ibuprofen 200 mg orange Caplets

Other Information (Other information)
  • store between 20o- 25o C (68o- 77o F)
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 Caplets**

**(Capsule-Shaped Tablets)

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING

Manufactured by: Avema Pharma Solutions

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 in 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 druing the last 3 months of pegnancy unless defintely 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 Caplet) (Active Ingredient (in each caplet))

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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