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Teva-Cephalexin: Uses, Side Effects and Dosage

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Facts
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Prescription (Rx)
Strength:
250 mg, 500 mg, 125 mg
Active ingredient:
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Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

Patient Medication Information: uses, side effects, how to take - Teva-Cephalexin

What is TEVA-CEPHALEXIN used for?

  • TEVA-CEPHALEXIN is used to treat certain bacterial infections in the:

    • respiratory tract;
    • ear (otitis media);
    • genitals and urinary tract;
    • bones and joints;
    • skin and soft tissue.
  • Antibacterial drugs like TEVA-CEPHALEXIN treat only bacterial infections. They do not treat viral infections, such as the common cold.

How does TEVA-CEPHALEXIN work?

TEVA-CEPHALEXIN is an antibiotic that:

  • Stops the growth of bacteria
  • Kills bacteria

What are the ingredients in TEVA-CEPHALEXIN?

Medicinal ingredients: Cephalexin (cephalexin monohydrate)

Non-medicinal ingredients:

250 mg Capsules: BLACK S-I-8114/S-I-8115, Colloidal Silicone Dioxide, D&CRed#28, Dry-Flo Starch, FD&CRed#40, FD&C Yellow #6, Gelatin, Magnesium Stearate, Sodium Lauryl Sulphate, Titanium Dioxide.

500 mg Capsules: Black Iron Oxide, BLACK S-I-8114/S-I-8115, Colloidal Silicone Dioxide, D&CRed#28, Dry-Flo Starch, FD&CRed#40, FD&C Yellow #6, Gelatin, Magnesium Stearate, Sodium Lauryl Sulphate, Titanium Dioxide.

250 mg Tablets: Colloidal Silicone Dioxide, Dry-Flo Starch, Magnesium Stearate, Microcrystalline Cellulose, Opadry Orange 18B130000 (consisting Hypromellose, Titanium Dioxide, Polyethylene Glycol (PEG) / Macrogol, Vanillin, FD&C Yellow #6 / Sunset Yellow FCF Aluminum Lake, Polysorbate 80, D&C Yellow #10 Aluminum Lake, FD&C Red 40 / Allura Red AC Aluminum Lake), Sodium Lauryl Sulphate, Sodium Starch Glycolate Type A.

500 mg Tablets: Colloidal Silicone Dioxide, Dry-Flo Starch, Magnesium Stearate, Microcrystalline Cellulose, Opadry Orange 18B130000 (consisting Hypromellose, Titanium Dioxide, Polyethylene Glycol (PEG) / Macrogol, Vanillin, FD&C Yellow #6 / Sunset Yellow FCF Aluminum Lake, Polysorbate 80, D&C Yellow #10 Aluminum Lake, FD&C Red 40 / Allura Red AC Aluminum Lake), Sodium Lauryl Sulphate, Sodium Starch Glycolate Type A.

125 mg / 5 mL Oral Solution: Citric Acid, Edetate Disodium Dihydrate, FD&C Yellow# 6, Flavour Natural & Artificial Orange/Banana, Sodium Benzoate, Sodium Citrate Dihydrate, Sodium Lauryl Sulphate, Sucrose.

250 mg / 5 mL Oral Solution: Citric Acid, Edetate Disodium Dihydrate, FD&C Red# 3, Flavour Natural & Artificial Wild Cherry, Sodium Benzoate, Sodium Citrate Dihydrate, Sodium Lauryl Sulphate, Sucrose.

Do not use TEVA-CEPHALEXIN if:

  • you are allergic to cephalexin, cephalosporin antibiotics or to any of the other ingredients in TEVA-CEPHALEXIN

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVA-CEPHALEXIN . Talk about any health conditions or problems you may have, including if you:

  • you are allergic to or react badly to penicillins or other antibiotics.
  • you have intestinal or bowel problems.
  • you have kidney problems.

  • you are pregnant or plan to be pregnant.

  • you are breast-feeding or plan to breast-feed.

Other warnings that you should know about:

  • Using antibiotics like TEVA-CEPHALEXIN may cause with Clostridium difficile-associated disease (CDAD). See “Serious side effects and what to do about them”, below.
  • TEVA-CEPHALEXIN may interfere with some blood and urine test results. Talk to your doctor if you are given a blood or urine test while taking TEVA-CEPHALEXIN.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

How to take TEVA-CEPHALEXIN:

  • Take TEVA-CEPHALEXIN orally on an empty stomach.

  • Although you may feel better early in treatment, TEVA-CEPHALEXIN should be used exactly as directed.
  • Misuse or overuse of TEVA-CEPHALEXIN could lead to the growth of bacteria that will not be killed by TEVA-CEPHALEXIN (resistance). This means that TEVA-CEPHALEXIN may not work for you in the future.
  • Do not share your medicine.

Usual dose:

Adult:

The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 1 g/day in divided doses every 6 hours.

Children:

The recommended daily dosage for children is 25 to 50 mg/kg/day in divided doses every 6 hours.

Overdose:

Symptoms of oral overdose may include:

  • nausea
  • vomiting
  • abdominal pain
  • diarrhea
  • bloody urine
If you think you have taken too much TEVA-CEPHALEXIN, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

What are possible side effects from using TEVA-CEPHALEXIN?

These are not all the possible side effects you may feel when taking TEVA-CEPHALEXIN. If you experience any side effects not listed here, contact your healthcare professional.

You may experience diarrhea, nausea, vomiting, loose stools, abdominal pain, diaper rash, inflammation of the vagina or discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations or symptoms that you do not understand. You should tell your health professional for of any of these symptoms as soon as possible.

Vertigo (loss of balance or unsteadiness), tinnitus (ringing in the ears), hearing loss and behavioural changes in young children have been reported.

TEVA-CEPHALEXIN may also cause effects such as yellowing of the whites of the eyes or skin (jaundice) or the inflammation of the liver (hepatitis).

Serious side effects and what to do about them

Symptom / effect

Talk to your healthcare

professional

Stop taking drug and get immediate medical help
Only if severeIn all cases
RARE

Symptoms of a severe bowel condition (Clostridium difficile

colitis):

  • persistent diarrhea
  • bloody or watery diarrhea
  • abdominal or
✓
  • stomach pain/cramping
  • blood/mucus in stool

Severe skin reactions:

  • skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge)
  • widespread rash with blisters and skin peeling on much of the body surface particularly around the mouth, nose, eyes and genitals.
✓

Severe Cutaneous Adverse

Reactions (SCAR) (severe skin

reactions that may also affect

other organs):

  • Skin peeling, scaling, or blistering (with or without pus) which may also affect your eyes, mouth, nose or genitals, itching, severe rash, bumps under the skin, skin pain, skin color changes (redness, yellowing, purplish)
  • Swelling and redness of eyes or face
✓
  • Flu-like feeling, fever, chills, body aches, swollen glands, cough
  • Shortness of breath, chest pain or discomfort

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health

Canada by:

  • Visiting the Web page on Adverse Reaction Reporting

    (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

  • Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Capsules & Tablets:

Store between 15°C and 25°C. Avoid excessive heat (30°C). Protect from light and humidity. Keep well closed. Keep out of reach and sight of children.

Oral Suspension:

Store dry powder between 15°C and 25°C. Avoid excessive heat (30°C). Protect from light and humidity.

Suspension may be kept for 14 days in a refrigerator without significant loss of potency (2 - 8°C). Do not freeze. Keep well closed. Shake well before using.

Keep out of reach and sight of children.

If you want more information about TEVA-CEPHALEXIN:

  • Talk to your healthcare professional
  • Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

M1B 2K9

Canada

www.tevacanada.com

Last revised: August 12, 2020

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 00342084

Revision date stated in the text: August 12, 2020

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Teva-Cephalexin

Rx or OTC
Prescription (Rx)?
DIN 00342084, 00342114, 00342092, 00342106, 00583413, 00583421
Schedule(s) PRESCRIPTION
Active ingredient(s) Cephalexin (cephalexin monohydrate)
Dosage form(s) Capsule, Powder For Suspension, Tablet
Route(s) of administration Oral
Drug class (WHO ATC)
  1. J Antiinfectives for systemic use
    1. J01 Antibacterials for systemic use
      1. J01D Other beta-lactam antibacterials
        1. J01DB First-generation cephalosporins
          1. J01DB01 Cefalexin
Company TEVA CANADA LIMITED
Current status Marketed
Strengths and forms
DIN Strength Dosage form(s) Current status
00342084 250 MG Capsule Marketed July 12, 2014
00342114 500 MG Capsule Marketed July 11, 2014
00342092 250 MG Powder For Suspension Marketed July 12, 2014
00342106 125 MG Powder For Suspension Marketed July 12, 2014
00583413 250 MG Tablet Marketed July 11, 2014
00583421 500 MG Tablet Marketed July 11, 2014

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.