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Cefexiclav Powder for Oral Suspension 50 mg/31.25 mg/5 mL

NAFDAC Reg. No. B4-6583 · Drug

Registered with NAFDAC. Registration activeAs of 27 October 2026 · synced automatically from official sources.
Product
Cefexiclav Powder for Oral Suspension 50 mg/31.25 mg/5 mL
NAFDAC number
B4-6583
Active ingredient
Cefixime; Clavulanic Acid (Clavulanate Potassium)
Strength
50 mg/5 mL; 31.25 mg/5 mL
Form
Suspension
Pack size
1 x 100 mL (in HDPE bottle)
Manufacturer
Not listed
Applicant (holder)
SJS Life Sciences Limited
Approved
6 Jul 2023
Status
Active View on NAFDAC ↗
Registration valid to
5 Jul 2028
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Cefexiclav Powder for Oral Suspension 50 mg/31.25 mg/5 mL is on the NAFDAC register with an active registration (B4-6583). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.

What Cefexiclav Powder for Oral Suspension 50 mg/31.25 mg/5 mL is used for

From the official U.S. FDA label for cefixime, the active ingredient registered with NAFDAC.

What it is used for

Cefixime for oral suspension is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months and older with the following infections: Uncomplicated Urinary Tract Infections (1.1) Otitis Media (1.2) Pharyngitis and Tonsillitis (1.3) Acute Exacerbations of Chronic Bronchitis (1.4) Uncomplicated Gonorrhea (cervical/urethral) (1.5) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefixime for oral suspension and other antibacterial drugs, cefixime for oral suspension should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. …

Possible side effects

Most common adverse reactions are gastrointestinal such as diarrhea (16%), nausea (7%), loose stools (6%), abdominal pain (3%), dyspepsia (3%), and vomiting. (6) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/m edwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most commonly seen adverse reactions in U.S. …

Do not use if

Cefixime for oral suspension is contraindicated in patients with known allergy to cefixime or other cephalosporins. Contraindicated in patients with known allergy to cefixime or other cephalosporins. (4)

Warnings

Hypersensitivity reactions including shock and fatalities have been reported with cefixime. Discontinue use if a reaction occurs. (5.1) Clostridium difficile associated diarrhea: Evaluate if diarrhea occurs. (5.2) 5.1 Hypersensitivity Reactions Anaphylactic/anaphylactoid reactions (including shock and fatalities) have been reported with the use of cefixime. Before therapy with cefixime is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary Available data from published observational studies, case series, and case reports over several decades with cephalosporin use, including cefixime, in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . …

General information only, not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Cefexiclav Powder for Oral Suspension 50 mg/31.25 mg/5 mL

Add the expiry date on your pack for a full Trust Score.

3 free checks left today Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Cefexiclav Powder for Oral Suspension 50 mg/31.25 mg/5 mL

What is in Cefexiclav Powder for Oral Suspension 50 mg/31.25 mg/5 mL?

Cefexiclav Powder for Oral Suspension 50 mg/31.25 mg/5 mL contains Cefixime; Clavulanic Acid (Clavulanate Potassium) (50 mg/5 mL; 31.25 mg/5 mL), as suspension, according to its NAFDAC registration record.

Is Cefexiclav Powder for Oral Suspension 50 mg/31.25 mg/5 mL registered with NAFDAC?

Yes. Cefexiclav Powder for Oral Suspension 50 mg/31.25 mg/5 mL is listed on the NAFDAC register under registration number B4-6583, and its registration is active as of 27 October 2026.

Has Cefexiclav Powder for Oral Suspension 50 mg/31.25 mg/5 mL been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Cefexiclav Powder for Oral Suspension 50 mg/31.25 mg/5 mL in our automatically synced alert list.

How can I check that my pack of Cefexiclav Powder for Oral Suspension 50 mg/31.25 mg/5 mL is genuine?

Run a free authenticity scan with the NAFDAC number B4-6583, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Cefexiclav Powder for Oral Suspension 50 mg/31.25 mg/5 mL used for?

Cefixime for oral suspension is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months and older with the following infections: Uncomplicated Urinary Tract Infections (1.1) Otitis Media (1.2) Pharyngitis and Tonsillitis (1.3) Acute Exacerbations of Chronic Bronchitis (1.4) Uncomplicated Gonorrhea (cervical/urethral) (1.5) To reduce the development (Summarised from the official U.S. FDA label for cefixime. Always follow your doctor or pharmacist.)

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Reviews are personal experiences from PillVera users, not medical advice. Report side effects to your doctor and to NAFDAC.