Acetaminophen and Ibuprofen (acetaminophen 250 mg ibuprofen 125 mg) Dailymed
Generic: acetaminophen and ibuprofen is used for the treatment of Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Arthritis, Juvenile Arthritis, Rheumatoid Asthma Bursitis Dysmenorrhea Gout Inflammation Menorrhagia Osteoarthritis Pain, Postoperative Pregnancy Trimester, Third Pregnancy, Abdominal Premenstrual Syndrome Rhinitis Spondylitis, Ankylosing Bronchial Hyperreactivity
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Active Ingredients (in Each Caplet)
Acetaminophen, USP 250 mg
Ibuprofen, USP 125 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever
Pain reliever
Indications & Usage Section
Uses
- temporarily relieves minor aches and pains due to:
- headache
- toothache
- backache
- menstrual cramps
- muscular aches
- minor pain of arthritis
Warnings Section
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.
Acetaminophen allergy alert:
may cause severe skin reactions. Symptoms may include:
- skin reddening
- bulers
- rash
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:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- bulers
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:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- you have symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- 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 SECTION
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 SECTION
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 Section
Directions
■ do not take more than directed
adults and children 12 years and over ■ take 2 caplets every 8 hours while symptoms persist children under 12 years ■ ask a doctor
■ do not take more than 6 caplets in 24 hours, unless directed by a doctor
Storage And Handling Section
Other information
- each caplet contains: sodium 3 mg
- read all warnings and directions before use.
- store at 20°C to 25°C (68°F to 77°F)
- avoid excessive heat above 40°C (104°F)
Inactive Ingredient Section
Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, glyceryl dibehenate, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulphate, stearic acid, titanium dioxide
Otc - Questions Section
Questions or comments?
call toll-free 1-888-235-2466
***This product is not manufactured or distributed by the owners of Advil ® Dual Action with Acetaminophen.
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.
Do not use with other medicines containing ACETAMINOPHEN; can cause liver damage.
Distributed by:
BIONPHARMA
Princeton, NJ 08540
MADE IN INDIA
R0524
L0000870
Code: TN/Drugs/ TN00002222/2006 948006836
Lot No.:
Exp. Date:
T00180R0424
Principal Display Panel
***Compare to the active ingredient in
Advil® Dual Action with
Acetaminophen
NDC 69452-394-64
a+health
Acetaminophen and
Ibuprofen (NSAID)
Tablets, 250 mg/125 mg
DUAL ACTION
PAIN RELIEVER
Contains 2 medicines
216 Caplets**
**capsule-shaped tablets
Front
Back Ply-1
Back Ply-2
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