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Gida / Rijista a Najeriya / Dr Hommels Cod Liver Oil## (incomplete smpc, strength format)

Dr Hommels Cod Liver Oil## (incomplete smpc, strength format)

NAFDAC Reg. A'a. A11-0361 · Magungunan miyagun ƙwayoyi

Rijista tare da NAFDAC. Rijista mai aikiAs of 5 November 2026 · synced automatically from official sources.
Product
Dr Hommels Cod Liver Oil## (incomplete smpc, strength format)
NAFDAC number
A11-0361
Active ingredient
Vitamin A; Vitamin D; Vitamin E; OMEGA 3
Strength
see Composition
Form
Oral liquid
Pack size
1 x 100 mL
Manufacturer
Not listed
Applicant (holder)
United African Laboratories Ltd
Approved
26 Jan 2023
Status
Active View on NAFDAC ↗
Registration valid to
25 Jan 2028
WHO alerts
None found
Community reports
None
Times checked
0

About the medicine: Vitamin d: uses, dosage and brands worldwide

What we found

  • Dr Hommels Cod Liver Oil## (incomplete smpc, strength format) is on the NAFDAC register with an active registration (A11-0361). 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.

How to use Dr Hommels Cod Liver Oil## (incomplete smpc, strength format)

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Who it is for

Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia. Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters and should continue this diet during treatment with omega-3-acid ethyl esters capsules. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters. …

How to take it and how often
  • Assess TG levels carefully before initiating therapy
  • Identify other causes (e.g., diabetes mellitus, hypothyroidism, medications) of high TG levels and manage as appropriate [see Indications and Usage ]
  • Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, and should continue this diet during treatment with omega-3-acid ethyl esters
  • In clinical studies, omega-3-acid ethyl esters capsules was administered with meals
  • The daily dose of omega-3-acid ethyl esters capsules is 4 grams per day
  • The daily dose may be taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily)
  • Patients should be advised to swallow omega-3-acid ethyl esters capsules whole
  • Do not break open, crush, dissolve, or chew omega-3-acid ethyl esters capsules
  • The daily dose of omega-3-acid ethyl esters capsules is 4 grams per day taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily)
  • Patients should be advised to swallow omega-3-acid ethyl esters capsules whole
  • Do not break open, crush, dissolve, or chew omega-3-acid ethyl esters capsules
Strengths it comes in

Omega-3-acid ethyl esters capsules, USP are supplied as 1 gram clear, transparent oblong capsules containing clear to light yellow colored solution imprinted with ‘AT 132’ with white ink. Capsules: 1 gram

Children
  • Safety and effectiveness
  • In pediatric patients have not been established
Older adults

A limited number of subjects older than 65 years were enrolled in the clinical trials of omega-3-acid ethyl esters. Safety and efficacy findings in subjects older than 60 years did not appear to differ from those of subjects younger than 60 years.

While you are taking it
  • Advise the patient to read the FDA-approved patient labeling (Patient Information)
  • Information for Patients Omega-3-acid ethyl esters should be used with caution in patients with known sensitivity or allergy to fish and/or shellfish [see Warnings and Precautions ]
  • Advise patients that use of lipid-regulating agents does not reduce the importance of adhering to diet [see Dosage and Administration ]
  • Advise patients not to alter omega-3-acid ethyl esters capsules in any way and to ingest intact capsules only [see Dosage and Administration ]
  • Instruct patients to take omega-3-acid ethyl esters as prescribed. …
Talk to a doctor first if
  • Omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any of its components
  • Omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any of its components
Medicines it may not mix with

Omega-3-acids may prolong bleeding time. Patients taking omega-3-acid ethyl esters capsules and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically. (7.1) 7.1 Anticoagulants or Other Drugs Affecting Coagulation Some trials with omega-3-acids demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in these trials has not exceeded normal limits and did not produce clinically significant bleeding episodes. Clinical trials have not been done to thoroughly examine the effect of omega-3-acid ethyl esters and concomitant anticoagulants. …

Warnings

In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy. (5.1) Omega-3-acid ethyl esters capsules may increase levels of low-density lipoprotein (LDL). Monitor LDL levels periodically during therapy. (5.1) Use with caution in patients with known hypersensitivity to fish and/or shellfish. (5.2) There is a possible association between omega-3-acid ethyl esters and more frequent recurrences of symptomatic atrial fibrillation or flutter in patients with paroxysmal or persistent atrial fibrillation, particularly within the first months of initiating therapy. …

Possible side effects

The most common adverse reactions (incidence >3% and greater than placebo) were eructation, dyspepsia, and taste perversion. To report SUSPECTED ADVERSE REACTIONS, contact Camber Pharmaceuticals Inc., at 1-866-495-8330 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

Pregnancy and breastfeeding

8.1 Pregnancy Risk Summary The available data from published case reports and the pharmacovigilance database on the use of omega-3-acid ethyl esters in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. …

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2023-10-06.

Label for vitamin a and vitamin d and vitamin e and omega, the active ingredient registered with NAFDAC.

Check your pack of Dr Hommels Cod Liver Oil## (incomplete smpc, strength format)

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3 free checks left today Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

About Dr Hommels Cod Liver Oil## (incomplete smpc, strength format)

What is in Dr Hommels Cod Liver Oil## (incomplete smpc, strength format)?

Dr Hommels Cod Liver Oil## (incomplete smpc, strength format) contains Vitamin A; Vitamin D; Vitamin E; OMEGA 3 (see Composition), as oral liquid, according to its NAFDAC registration record.

Is Dr Hommels Cod Liver Oil## (incomplete smpc, strength format) registered with NAFDAC?

Yes. Dr Hommels Cod Liver Oil## (incomplete smpc, strength format) is listed on the NAFDAC register under registration number A11-0361, and its registration is active as of 5 November 2026.

Has Dr Hommels Cod Liver Oil## (incomplete smpc, strength format) been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Dr Hommels Cod Liver Oil## (incomplete smpc, strength format) in our automatically synced alert list.

How can I check that my pack of Dr Hommels Cod Liver Oil## (incomplete smpc, strength format) is genuine?

Run a free authenticity scan with the NAFDAC number A11-0361, 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.

How do I take Dr Hommels Cod Liver Oil## (incomplete smpc, strength format)?

Follow your prescription or the leaflet in your pack. The official label says: Assess TG levels carefully before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, medications) of high TG levels and manage as appropriate [see Indications and Usage (1)] . Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, and should continue this diet during treatment with om…

What is Dr Hommels Cod Liver Oil## (incomplete smpc, strength format) used for?

Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia. Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters and should continue this diet during treatment with omega-3-acid ethyl ester (Summarised from the official U.S. FDA label for vitamin a and vitamin d and vitamin e and omega. Always follow your doctor or pharmacist.)

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