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AMOXICILLIN 400 MG-5 ML SUS 75 ML

  • Manufacturer Name : AUROBINDO PHARM
  • MFG # : 65862007175
  • NDC : 65862007175
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind AB
Drug Category NJ
Drug Type Code N
FDA Approval Date 08/07/2008
FDA Therap Equiv ML
HCPCS -
Market Entry Date -
Medical Coverage -
Termination Date 1
Unit 75
Units Per Pkg 01/17/2007
Active Ingredients 2707 amoxicillin trihydrate 61336707
AHFS Class 8121608 AMINOPENICILLIN ANTIBIOTICS
DEA Class NC
Dose Form SUSPENSION, RECONSTITUTED, ORAL (ML)
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 42683 amoxicillin ORAL SUSP RECON 400 MG/5ML
Inactive Ingredients 10141 red dye; 2332 sodium citrate 68042; 2598 sucrose 57501; 3785 edetic acid 60004
OMP Family -
Product Category RX Pharmaceuticals
Strength 400MG-5ML
Common Brand Name COMMON BRAND NAME(S): Amoxil
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: methotrexate. Amoxicillin may cause false positive results with certain diabetic urine testing products (cupric sulfate-type). This drug may also affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug.
Allocation Period -
Case Quantity 48
Drug Form Pack Size 75
Form SUSPENSION
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 75
How to Use HOW TO USE: Shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Take this medication by mouth with or without food as directed by your doctor, usually every 8 or 12 hours. The dosage is based on your medical condition and response to treatment. You may add the measured dose to formula, milk, juice, water, or ginger ale just before use. Drink all of the mixture to get the full dose. Do not mix ahead of time for future use. Drink plenty of fluids while using this medication unless your doctor tells you otherwise. For the best effect, take this antibiotic at evenly spaced times. To help you remember, take this medication at the same time(s) every day. Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection. Tell your doctor if your condition lasts or gets worse.
Missed Dose MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to. With prolonged treatment, lab and/or medical tests (such as kidney/liver function, complete blood counts) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: diarrhea that doesn't stop, severe vomiting, a severe decrease in the amount of urine, or seizures.
Phonetic Pronunciation (a-MOX-i-SIL-in)
Precautions PRECAUTIONS: Before taking amoxicillin, tell your doctor or pharmacist if you are allergic to it; or to penicillin or cephalosporin antibiotics; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, a certain type of viral infection (infectious mononucleosis). Amoxicillin suspension may contain sugar. Caution is advised if you have diabetes or any other condition that requires you to limit/avoid sugar in your diet. Ask your doctor or pharmacist about using this product safely. Amoxicillin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using amoxicillin before having any immunizations/vaccinations. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Amoxicillin passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Nausea, vomiting, or diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. This medicine may cause temporary staining of the teeth. Proper brushing will usually remove any stains and prevent them from occurring. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms. Tell your doctor right away if you have any serious side effects, including: signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), easy bruising or bleeding. This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool. If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever that doesn't go away, new or worsening lymph node swelling, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Amoxicillin can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Get medical help right away if you develop any rash. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Refrigeration may improve the taste of this medicine. Certain brands of this medicine may expire earlier when stored at room temperature than when refrigerated. Check the bottle or ask your pharmacist to see if (and for how long) you can store this medicine at room temperature. Do not store in the bathroom. Keep all medications away from children and pets. Discard any unused portion after 14 days since the drug loses potency after that time. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: Amoxicillin is used to treat a wide variety of bacterial infections. This medication is a penicillin-type antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. Amoxicillin is also used with other medications to treat stomach/intestinal ulcers caused by the bacteria H. pylori and to prevent the ulcers from returning.

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AMOXICILLIN 400 MG-5 ML SUS 75 ML is manufactured by AUROBINDO PHARM.
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