FDA Label for Acetaminophen Ibuprofen (nsaid)

View Indications, Usage & Precautions

Acetaminophen Ibuprofen (nsaid) Product Label

The following document was submitted to the FDA by the labeler of this product Dr. Reddy's Labortories 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.

Active Ingredients (In Each Caplet)

Acetaminophen USP, 250 mg

Ibuprofen USP, 125 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purposes

Pain Reliever

Uses

•temporarily relieves minor aches and pains due to:
- •backache
- •muscular aches
- •minor pain of arthritis
- •headache
- •toothache
- •menstrual cramps

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:

•skin reddening
•blisters
•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
•blisters

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

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 (1-800-222-1222). 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

•
adults and children 12 years and over
children under 12 years

•do not take more than 6 caplets in 24 hours, unless directed by a doctor

Storage And Handling

Other information

•read all warnings and directions before use. Keep carton.
•store at 20-25°C (68-77°F)
•avoid excessive heat above 40°C (104°F)

Inactive Ingredient

Inactive ingredients

black iron oxide, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, glyceryl dibehenate, hypromellose, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, sodium lauryl sulfate, titanium dioxide

Otc - Questions

Questions or comments?

call 1-888-375-3784 Weekdays (8 AM to 8 PM EST)

Distributed By:

Dr. Reddy's Laboratories, Inc.

Princeton, NJ 08540

Made in India

Rev: 02/25

Package Label Principal Display Panel Section

250backcarton - 250backcarton

* Please review the disclaimer below.

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