Ibuprofen Softgels: Package Insert and Label Information

IBUPROFEN SOFTGELS- ibuprofen capsule, liquid filled
Selder, S.A. de C.V.

Active ingredient

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

Purpose

Pain reliever/fever reducer

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding.

The chances are 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.

Do not use

■ 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

■ 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

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

When using this product

• take with food or milk if stomach upset occurs
  

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

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.

Heart attack and stroke warning

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

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.

Directions

• do not take more than directed
• the smallest effective dose should be used
• Adults and children 12 years and older: take 1 softgel every 4 to 6 hours while symptoms persist
• if pain or fever does not respond to 1 softgel, 2 softgels may be used
• do not exceed 6 softgels in 24 hours, unless directed by a doctor
• Children under 12 years: ask a doctor

Inactive Ingredients

ammonium hydroxide, FD&C green #3 aluminum lake, gelatin, iron oxide black, medium chain triglycerides, polyethylene glycol, propylene glycol, potassium hydroxide, purified water, shellac, sorbitol sorbitan, sorbitan monooleate

Package/Label Principal Display Panel

XL-DOL ibuprofen 200mg

IBUPROFEN SOFTGELS ibuprofen 200 mg capsule, liquid filled

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63654-363 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg

Inactive Ingredients Ingredient Name Strength AMMONIA FD&C GREEN NO. 3 GELATIN FERROSOFERRIC OXIDE MEDIUM-CHAIN TRIGLYCERIDES POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL POTASSIUM HYDROXIDE WATER SHELLAC SORBITAN MONOOLEATE

Product Characteristics Color GREEN Score no score Shape CAPSULE Size 15mm Flavor Imprint Code 133 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63654-363-40 1 BOTTLE in 1 CARTON contains a BOTTLE 1 40 CAPSULE, LIQUID FILLED in 1 BOTTLE This package is contained within the CARTON (63654-363-40)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079205 12/22/2014

Labeler — Selder, S.A. de C.V. (824413629)

Revised: 12/2018 Selder, S.A. de C.V.