International reference: 2 US FDA recalls for this ingredient

Out-of-specification test results obtained for identification testing based on HPTLC analysis. (euphrasia)

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. (chamomile)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Ghana.

Valid Ghana · FDA Ghana

OPTISOFT SOOTHING EYE DROPS (Each ml contains Sodium Chloride/Chamomile/Euphrasia 0.5% w/v/0.5%w/v/0.5%w/v)

Sodium Chloride/Chamomile/Euphrasia

FDA/SD.265-050534 Sodium Chloride/Chamomile/Euphrasia 0.5% w/v/0.5%w/v/0.5%w/v

What it does

Chamomile is a natural remedy often used for its calming effects.

Commonly used for: anxiety, insomnia, stomach upset, inflammation

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Sourcing - Kenya only

Registration & product details

Registration no.
FDA/SD.265-050534
Registration date
2026-12-05
Expiry date
2031-12-01
Status
Valid
Active ingredient
Sodium Chloride/Chamomile/Euphrasia
Strength
0.5% w/v/0.5%w/v/0.5%w/v
Pack size
-
Therapeutic class
-
RxNorm RxCUI
1309226
Manufacturer / MAH
Stericon Pharma
Country of origin
INDIA
Manufacturer location
No. 9R, Sub Layout of Plot No.9, 1st Phase, Bommasandra Industrial Area, RK Twp, Yarandahalli, Karnataka 560099, India

Source: Food and Drugs Authority · fetched 2026-05-22 02:34:56 · updated 2026-10-27 04:00:11

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About chamomile

Chamomile is a natural remedy often used for its calming effects.

What it treats

  • anxiety
  • insomnia
  • stomach upset
  • inflammation

How it works

Chamomile helps relax the body and mind, which can reduce stress and promote sleep.

Who it's for

It is suitable for adults and children who need relief from mild anxiety or sleep issues.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About euphrasia

Euphrasia, commonly known as eyebright, is a herbal remedy often used to relieve eye irritation and discomfort.

What it treats

  • eye irritation
  • allergic conjunctivitis
  • dry eyes

How it works

Euphrasia is believed to have soothing properties that help reduce redness and irritation in the eyes.

Who it's for

Euphrasia is suitable for adults and children experiencing minor eye issues.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: chamomile

Chamomile, derived from the flower heads of Matricaria chamomilla or Chamaemelum nobile, is an herbal remedy commonly used for its calming effects and as a mild sedative. It has been traditionally used to help with anxiety, insomnia, and digestive issues. Chamomile contains various bioactive compounds, including flavonoids and terpenoids, which contribute to its therapeutic properties.

Indications

  • Anxiety
  • Insomnia
  • Digestive disorders
  • Mild sedation
  • Anti-inflammatory conditions

Dosage

Children: Refer to herbal product guidelines, as doses can vary widely based on preparation.

Adults: Refer to herbal product guidelines, as doses can vary widely based on preparation.

Mechanism of action

Chamomile's mechanism of action is primarily attributed to its flavonoid content, particularly apigenin, which binds to benzodiazepine receptors in the brain. This binding enhances the effect of GABA, an inhibitory neurotransmitter, leading to sedation and anxiolytic effects. Additionally, chamomile exhibits anti-inflammatory and antioxidant properties, contributing to its overall therapeutic profile.

Pharmacodynamics

The pharmacodynamic effects of chamomile include anxiolytic, sedative, anti-inflammatory, and antispasmodic actions. Its ability to promote relaxation and reduce anxiety is significant, and it may also alleviate gastrointestinal discomfort through its spasmolytic effects on smooth muscle. Chamomile's antioxidant properties help in neutralizing free radicals, which can contribute to its health benefits.

Pharmacokinetics

Chamomile is typically administered orally, and its active constituents are absorbed through the gastrointestinal tract. The onset of action may vary based on the formulation and individual metabolism. Chamomile is metabolized in the liver, and its metabolites are excreted primarily via the urine. The half-life of chamomile components is not well-established, and more research is needed to fully understand its pharmacokinetic profile.

Adverse effects

  • Allergic reactions, including skin rashes and anaphylaxis
  • Sedation or drowsiness
  • Nausea and vomiting

Interactions

  • May enhance the effects of anticoagulants, increasing the risk of bleeding
  • Potential interaction with sedative medications, leading to increased sedation
  • May interact with antiplatelet drugs, increasing the risk of bleeding

Precautions

  • Use with caution in individuals with allergies to plants in the Asteraceae family, such as ragweed, marigolds, and daisies
  • Caution is advised in patients with bleeding disorders or those taking anticoagulants
  • Should be used with caution during surgery due to its potential effects on bleeding

Pregnancy

Chamomile is generally considered safe in small amounts, but high doses should be avoided due to potential risks of miscarriage or uterine contractions.

Breast-feeding

Chamomile is considered safe in moderate amounts during breastfeeding, but excessive consumption should be avoided due to potential effects on the infant.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Dried flowers (for tea)
  • Essential oil
  • Liquid extracts
  • Capsules or tablets

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: euphrasia

Euphrasia, commonly known as eyebright, is a flowering plant from the family Orobanchaceae. It has been traditionally used for its potential therapeutic effects on eye-related conditions, particularly conjunctivitis and other inflammatory eye disorders. Its preparation is often used in herbal medicine, although scientific evidence for its efficacy is limited. The plant contains various phytochemicals that may exert mild anti-inflammatory and astringent effects.

Indications

  • Allergic conjunctivitis
  • Acute conjunctivitis
  • Eye fatigue
  • Irritation of the eyes

Dosage

Children: Refer to established herbal preparation guidelines for dosage in children, as specific dosing information is not available in conventional pharmacological references.

Adults: Refer to established herbal preparation guidelines for dosage, as specific dosing information is not available in conventional pharmacological references.

Mechanism of action

Euphrasia is believed to exert its effects through a combination of astringent, anti-inflammatory, and mild antiseptic properties. The active components may act on mucous membranes, providing relief from irritation and inflammation. The specific molecular mechanisms and pathways of action are not well-characterized in the literature.

Pharmacodynamics

The pharmacodynamics of euphrasia suggests that its constituents may modulate inflammatory responses and provide symptomatic relief in eye conditions. It may influence local circulation and promote healing by reducing inflammation and irritation.

Pharmacokinetics

Limited pharmacokinetic data are available for euphrasia due to its use primarily as a herbal remedy. Absorption, distribution, metabolism, and excretion characteristics have not been well-studied. The effects are generally localized to the site of application, particularly in ocular formulations.

Pregnancy

Euphrasia is considered safe during pregnancy, but limited data is available. Consultation with a healthcare provider is recommended.

Breast-feeding

Euphrasia is generally regarded as safe during breastfeeding, though it is advisable to consult a healthcare provider.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Eyedrops
  • Ointment
  • Homeopathic preparations

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.