Acetaminophen And Ibuprofen Back Pain Tablet
FDA Label NDC 70010-213

Acetaminophen 250 mg

Ibuprofen 125 mg (NSAID**)

**nonsteroidal anti-inflammatory drug

Pain reliever

Pain reliever

• temporarily relieves minor aches and pains due to:
o backache

o muscular aches

o minor pain of arthritis
o headache
o toothache
o menstrual cramps

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.

• 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

• 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

• 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

• Take with food or milk if stomach upset occurs

• 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

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.

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.

• 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

• 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)

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.

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

NDC 70010-213-26

^†Compare to the Active Ingredients
of Advil ^® Dual Action Back Pain

Contains 2 Medicines

Acetaminophen and

Ibuprofen (NSAID) Tablets

250 mg/125 mg

Dual Action Pain Reliever

Back Pain 8 Hour Relief

18 Caplets*

(*capsule-shaped tablets)

Ibu-apap-18s-cont-labl (Ibu Apap 18s Cont Labl)

NDC 70010-213-26
†Compare to the Active Ingredients
of Advil® Dual Action Back Pain
Contains 2 Medicines
Acetaminophen and
Ibuprofen (NSAID)
Tablets
250 mg/125 mg
Dual Action Pain Reliever
Back Pain
8 Hour Relief
18 Caplets*
(*capsule-shaped tablets)

Ibu-apap-18s-cont-carton (Ibu Apap 18s Cont Carton)