Drug Facts
Composition & Profile
Identifiers & Packaging
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)
- 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)
Overview
Uses temporarily relieves minor aches and pains due to: backache muscular aches minor pain of arthritis headache toothache menstrual cramps
Indications & Usage
Uses temporarily relieves minor aches and pains due to: backache muscular aches minor pain of arthritis headache toothache menstrual cramps
Dosage & Administration
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
Warnings & Precautions
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.
Purpose
Purposes Pain reliever
Do Not Use
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
When Using
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)
Stop Use & Ask a Doctor
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
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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Questions
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
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