Other
Drug Facts
Ibuprofen 100 Tablet, Coated
FDA Label NDC 73598-1102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jhk Inc Dba American Safety & First Aid for the product Ibuprofen 100 (NDC 73598-1102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each tablets), purpose, use, allergy alert, stomach bleeding warning, do not use, ask a doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 #2Questions?
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)
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)
* Please review the disclaimer below.
