IBUPROFEN 100, IBUPROFEN 250 IBUPROFEN JHK INC DBA AMERICAN SAFETY & FIRST AID FDA Approved Use temporarily relieves fever and minor aches and pains associated with: common cold backache headache toothache arthritis muscular aches menstrual cramps

IBUPROFEN 100

(+1 other brands)
Generic: IBUPROFEN
FunFoxMeds box
Substance Ibuprofen
Route
ORAL
Applications
ANDA072096

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (In Each Tablets) Ibuprofen USP 200 mg (NSAID) *Nonsteroidal Anti-Inflammatory Drug
Inactive Ingredients
Inactive Ingredients crosscarmellose sodium contains one or more of these ingredients FD& C Blue #2 FD& C red #40 FD& C Yellow #6 hypromellose iron oxide red lactose monohydrate magnesium stearate maltodextrin medium chain triglycerides microcrystalline cellulose polydextrose polyethylene glycol polyvinyl alcohol povidone (K-30) silicon dioxide sodium starch glycolate starch stearic acid talc titanium dioxide triacetin
Strengths
200 mg
Quantities
100 tablet 100 tablets 2 tablets 250 tablet 250 tablets
Treats Conditions
Use Temporarily Relieves Fever And Minor Aches And Pains Associated With Common Cold Backache Headache Toothache Arthritis Muscular Aches Menstrual Cramps
Pill Appearance
Shape: round Color: brown Imprint: G2

Identifiers & Packaging

Container Type BOX
UNII
WK2XYI10QM
Packaging

PRINCIPAL DISPLAY PANEL - 100 Tablet Packet Box This product is not manufactured or distributed by Pfizer Consumer Healthcare Owner of the registered trademark Advil ® . Product #1102 Ibuprofen Pain Reliever/Fever Reducer Active ingredient: Ibuprofen Temporary relief from pain, fever and inflammation Soothes muscles aches and minor arthritis pain Non-drowsy, aspirin-free formula These quality comfort tablets are formulated and packaged for use in the workplace and meet ANSI Z308.1-2015 standards. They are sealed in tamper-evident packets for safety and convenience. 100 Tablets • 2 Tablets Per Packet PRINCIPAL DISPLAY PANEL - 100 Tablet Packet Box; PRINCIPAL DISPLAY PANEL - 250 Tablet Packet Box Product #1104 Ibuprofen Pain Reliever/Fever Reducer Active ingredient: Ibuprofen Temporary relief from pain, fever and inflammation Soothes muscles aches and minor arthritis pain Non-drowsy, aspirin-free formula These quality comfort tablets are formulated and packaged for use in the workplace and meet ANSI Z308.1-2015 standards. They are sealed in tamper-evident packets for safety and convenience. 250 Tablets • 2 Tablets Per Packet PRINCIPAL DISPLAY PANEL - 250 Tablet Packet Box

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 100 Tablet Packet Box This product is not manufactured or distributed by Pfizer Consumer Healthcare Owner of the registered trademark Advil ® . Product #1102 Ibuprofen Pain Reliever/Fever Reducer Active ingredient: Ibuprofen Temporary relief from pain, fever and inflammation Soothes muscles aches and minor arthritis pain Non-drowsy, aspirin-free formula These quality comfort tablets are formulated and packaged for use in the workplace and meet ANSI Z308.1-2015 standards. They are sealed in tamper-evident packets for safety and convenience. 100 Tablets • 2 Tablets Per Packet PRINCIPAL DISPLAY PANEL - 100 Tablet Packet Box
  • PRINCIPAL DISPLAY PANEL - 250 Tablet Packet Box Product #1104 Ibuprofen Pain Reliever/Fever Reducer Active ingredient: Ibuprofen Temporary relief from pain, fever and inflammation Soothes muscles aches and minor arthritis pain Non-drowsy, aspirin-free formula These quality comfort tablets are formulated and packaged for use in the workplace and meet ANSI Z308.1-2015 standards. They are sealed in tamper-evident packets for safety and convenience. 250 Tablets • 2 Tablets Per Packet PRINCIPAL DISPLAY PANEL - 250 Tablet Packet Box

Overview

Use temporarily relieves fever and minor aches and pains associated with: common cold backache headache toothache arthritis muscular aches menstrual cramps

Indications & Usage

Use temporarily relieves fever and minor aches and pains associated with: common cold backache headache toothache arthritis muscular aches menstrual cramps

Dosage & Administration

Directions do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) Adults: 1 tablet every 4 to 6 hours while symptoms occur; if pain or fever does not respond to 1 tablet, 2 tablets may be used, but do not exceed 6 tablets in 24 hours unless directed by a doctor. Children under 12 years: Ask a doctor.

Warnings & Precautions
Warnings Allergy Alert Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives asthma (wheezing) facial swelling 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 Do not use if you 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 a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant) drug under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs long term continuous use may increase the risk of heart attack or stroke 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 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Purpose

Purpose pain reliever/fever reducer

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

When Using

When using this product take with food or milk if stomach upset occurs long term continuous use may increase the risk of heart attack or stroke

Stop Use & Ask a Doctor

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 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

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.

Storage & Handling

Other Information do not use if packet is opened or torn Store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)

Questions

Questions? 1-866-651-3660 Monday-Friday 8:00am-5:00pm EST


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