FDA Label for Ibuprofen 100

View Indications, Usage & Precautions

Ibuprofen 100 Product Label

The following document was submitted to the FDA by the labeler of this product Jhk Inc Dba American Safety & First Aid. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other

Drug Facts

Active Ingredient (In Each Tablets)

Ibuprofen, USP 200 mg (NSAID)

*Nonsteroidal Anti-Inflammatory Drug

Purpose

pain reliever/fever reducer

Use

temporarily relieves fever and minor aches and pains associated with:

common cold
backache
headache
toothache
arthritis
muscular aches
menstrual cramps

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

Otc - Stop Use

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

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 right away.

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.

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)

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,

Questions?

1-866-651-3660 Monday-Friday

8:00am-5:00pm EST

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 - ibuprofen 01

Principal Display Panel - 250 Tablet Packet Box

Product #1104