Acetaminophen And Ibuprofen Tablet
FDA Label NDC 70010-131

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Granules Pharmaceuticals Inc. for the product Acetaminophen And Ibuprofen (NDC 70010-131). 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 active ingredients (in each caplet), purposes, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients (in Each Caplet)

→ Purposes

→ Uses

→ Warnings

→ 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

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredients (In Each Caplet)

Acetaminophen 250 mg

Ibuprofen 125 mg (NSAID**)

**nonsteroidal anti-inflammatory drug

Purposes

Pain reliever

Uses

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

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
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

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.

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.

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

Other Information

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

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulfate, stearic acid and titanium dioxide.