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Acetaminophen and Ibuprofen Back Pain (acetaminophen 250 mg ibuprofen 125 mg) Dailymed

  1. Human OTC
    • Drug Classes
  3. Aurohealth LLC

Generic: acetaminophen and ibuprofen

Acetaminophen and Ibuprofen Back Pain tablet, film coated - (acetaminophen 250 mg ibuprofen 125 mg) image

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    COLOR: yellow

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Drug Facts


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

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.

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


colloidal silicon dioxide, corn starch, hydroxypropyl methylcellulose, lactose monohydrate, pregelatinized starch (corn), sodium starch glycolate, stearic acid, titanium dioxide, triacetin, yellow iron oxide

Questions Or Comments?


 Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown RoadEast Windsor, NJ 08520 Made in India Code: TS/DRUGS/16/2014

Package Label-principal Display Panel - 250 Mg/125 Mg (10 Caplets Bottle Label)


AUROHEALTH NDC 58602-895-03 CONTAINS 2 MEDICINES Acetaminophen + Ibuprofen Acetaminophen and Ibuprofen (NSAID) Tablets 250 mg/125 mg BACK PAIN Pain Reliever 10 Caplets* *Capsule-Shaped Tablets

Package Label-principal Display Panel - 250 Mg/125 Mg (10 Caplets Bottle Carton Label)


AUROHEALTH NDC 58602-895-03

 **Compare to the active ingredients of Advil Dual Action With Acetaminophen Back Pain CONTAINS 2 MEDICINES  Acetaminophen + Ibuprofen  Acetaminophen and Ibuprofen (NSAID) Tablets 250 mg/125 mg BACK PAIN Pain Reliever 8 HOUR RELIEF 10 Caplets* *Capsule-Shaped Tablets

Package Label-principal Display Panel - 250 Mg/125 Mg Blister Carton (2 (1 X 2) Caplets)


AUROHEALTH NDC 58602-895-61

 **Compare to the active ingredients of Advil Dual Action With Acetaminophen Back Pain CONTAINS 2 MEDICINES Acetaminophen + Ibuprofen Acetaminophen and Ibuprofen (NSAID) Tablets 250 mg/125 mg √    Backache                            √    Headache √    Muscular Aches                  √    Toothache √    Minor Pain of Arthritis         √    Menstrual Cramps BACK PAIN Pain Reliever Each caplet contains Acetaminophen 250 mg and Ibuprofen 125 mg 8 HOUR RELIEF 2 Caplets* *Capsule-Shaped Tablets

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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