FDA Label for Counteract IB
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- BOXED WARNING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Counteract IB Product Label
The following document was submitted to the FDA by the labeler of this product Melaleuca, Inc. 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.
Otc - Active Ingredient
Active Ingredient (in each tablet)
Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Otc - Purpose
Purpose
Pain reliever/fever reducer
Indications & Usage
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
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
- 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
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning:This product contains an nonsteroidal anti-inflammatory drug (NSAID), which may cause severe bleeding. The chances are higher if you:
Otc - Do Not Use
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Otc - Ask Doctor
Ask a doctor before use if
- you have problems or serious side effects from taking pain relievers or fever reducers
- the 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 have asthma
- you are taking a diuretic
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- under a doctor's care for any serious condition
- taking any other drug
- taking any other drug containing an NSAID (prescription or nonprescription)
- taking a blood thinning (anticoagulant) or steroid drug
Otc - 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
Otc - Stop Use
Stop use and ask a doctor if
- you experience any of the following signs of bleeding:
- feel faint
- vomit blood
- have blood ro 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 (1-800-222-1222).
Dosage & Administration
Directions
- do not take more than directed
- the smallest effective dose should be used
- take 1 tablet every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 tablet, 2 tablets may be used
- do not exceed 6 tablets in 24 hours unless directed by a doctor
- Children under 12 years:
- ask a doctor
Adults and children 12 years and older:
Storage And Handling
Other information
- Store between 20 to 25°C (68 to 77°F)
- Read all warnings and directions before use
- save carton for complete drug facts information and warnings
Inactive Ingredient
Inactive ingredients collodial silicon dioide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide
Otc - Questions
Questions of comments? call 1-800-282-3000
Boxed Warning
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Package Label.Principal Display Panel
* Please review the disclaimer below.