FDA Label for Acetaminophen, Ibuprofen
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH CAPLET)
- PURPOSES
- INDICATIONS & USAGE
- WARNINGS
- ACETAMINOPHEN LIVER DAMAGE WARNING:
- OTHER
- NSAID STOMACH BLEEDING WARNING:
- HEART ATTACK AND STROKE WARNING:
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PRINCIPAL DISPLAY PANEL
Acetaminophen, Ibuprofen Product Label
The following document was submitted to the FDA by the labeler of this product Glenmark Therapeutics Inc., Usa. 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.
Active Ingredients (In Each Caplet)
Acetaminophen 250 mg
Ibuprofen 125 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever
Pain reliever
Indications & Usage
Uses
• temporarily relieves minor aches and pains due to:o headacheo toothacheo backacheo menstrual crampso muscular acheso minor pain of arthritis
Warnings
Warnings
Acetaminophen Liver Damage Warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
• with other drugs containing acetaminophen• more than 6 caplets in 24 hours, which is the maximum daily amount for this product• 3 or more alcoholic drinks every day while using this product
Other
Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include:
|
|
|
If skin reaction occurs, stop use and seek medical help right away.
NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
|
|
|
|
|
|
|
If an allergic reaction occurs, stop use and seek medical help right away.
Nsaid Stomach Bleeding Warning:
This product contains an 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
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.
Do Not Use
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist• if you have ever had an allergic reaction to acetaminophen or any other pain reliever• right before or after heart surgery
Ask A Doctor Before Use If
• you have liver disease• stomach bleeding warning applies to you• you have problems or serious side effects from taking pain relievers• you have a history of stomach problems, such as heartburn• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke• 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:o feel fainto vomit bloodo have bloody or black stoolso have stomach pain that does not get better
• you have symptoms of heart problems or stroke:o chest paino trouble breathingo weakness in one part or side of bodyo slurred speecho leg swelling
• pain gets worse or lasts more than 10 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 at 20 weeks or later in 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions
• do not take more than directed• take 2 caplets every 8 hours while symptoms persist• ask a doctor• do not take more than 6 caplets in 24 hours, unless directed by a doctor
adults and children 12 years and over | |
children under 12 years |
Storage And Handling
Other information
• read all warnings and directions before use. Keep carton.• store at 20°C to 25°C (68°F to 77°F)• avoid excessive heat above 40°C (104°F)
Inactive Ingredient
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, ferrosoferric oxides, glyceryl dibehenate, hypromellose, iron oxide yellow, iron oxide red, polydextrose, povidone, polyethylene glycol, propylene glycol, shellac, pregelatinized starch and titanium dioxide
Otc - Questions
Questions or comments?
call weekdays 9 AM to 5 PM at 1 (888) 721-7115
Distributed by:
Glenmark Therapeutics Inc., USA
Mahwah, NJ 07430
March 2023
Principal Display Panel
NDC 72657-157-74
Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets
Pain Reliever
144’sCaplets*
*Capsule-Shaped Tablets
* Please review the disclaimer below.