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| Product NDC Code | 58602-895 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Drug Name | Acetaminophen and ibuprofen back pain |
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| Type | Brand | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pharm Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Dosage Form | TABLET, FILM COATED | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| RxCUI drug identifier | 2387532 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Application Number | ANDA218359 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Labeler Name | Aurohealth LLC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredients (in each caplet) Acetaminophen USP 250 mg Ibuprofen USP 125 mg (NSAID*) *nonsteroidal anti-inflammatory drug
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
| adults and children 12 years and over |
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| children under 12 years |
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily relieves minor aches and pains due to: backache muscular aches minor pain of arthritis headache toothache menstrual cramps
Purpose
Information about the drug product’s indications for use.Purposes Pain reliever
Spl product data elements
Usually a list of ingredients in a drug product.Acetaminophen and Ibuprofen Back Pain Acetaminophen and Ibuprofen ACETAMINOPHEN ACETAMINOPHEN IBUPROFEN IBUPROFEN SILICON DIOXIDE STARCH, CORN HYPROMELLOSE 2910 (15 MPA.S) LACTOSE MONOHYDRATE SODIUM STARCH GLYCOLATE TYPE A POTATO PALMITOSTEARIC ACID TITANIUM DIOXIDE TRIACETIN FERRIC OXIDE YELLOW Light Yellow to Yellow Biconvex AI;II
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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)
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 Container Carton (10 Caplets)
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 PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg Blister Carton (2 (1 x 2) Caplets)
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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 doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.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 Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/16/2014
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product take with food or milk if stomach upset occurs
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)
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API