GENERIC NAME OF THE MEDICINAL PRODUCT:

Hydroxyzine HCl Tablets USP 10mg
Hydroxyzine HCl Tablets USP 25mg
Hydroxyzine HCl Tablets USP 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Hydroxyzine HCl Tablets USP 10mg
Each film coated Tablet contains:
Hydroxyzine Hydrochloride USP…………...10mg
Excipients……………………………………... q. s
Colours: Titanium Dioxide BP


b) Hydroxyzine HCl Tablets USP 25mg
Each film coated Tablet contains:
Hydroxyzine Hydrochloride USP…………….25mg
Excipients………………………………………. q.s
Colours: Carmoisine Lake

c) Hydroxyzine HCl Tablets USP 50mg
Each film coated Tablet contains:
Hydroxyzine Hydrochloride USP…………….50mg
Excipients………………………………………. q.s
Colours: Red Iron Oxide

THERAPEUTIC INDICATIONS:

Hydroxyzine Hydrochloride is indicated to assist in the management of anxiety in adults. Hydroxyzine Hydrochloride is indicated for the management of pruritus associated with acute and chronic urticaria, including cholinergic and physical types, and atopic and contact dermatitis in adults and children.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
*Not suitable for children under 12 years.
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).
Store at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature].
Dosage: As directed by the Physician.
Attach dispensing label as per end country.

Hydroxyzine HCl Tablets USP 10mg Technical Specification:

Product Name:                                        Hydroxyzine HCl Tablets USP 10mg
Brand Name:Generic
Strength:10mg, 25mg, 50mg
Dosage Form:Tablet (Film-coated)
Route of Administration:Via oral Route
Packing:100s, 500s, 1000s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-allergic, Antihistamine
Indication: Hydroxyzine is used to treat itching caused by allergies. It is an antihistamine and works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Hydroxyzine may also be used short-term to treat anxiety or to help you feel sleepy/relaxed before and after surgery.
Storage:Store at 20° to 25° C (68° to 77° F).

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Hydroxyzine HCl Tablets USP 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  •  Hydroxyzine HCl Tablets USP 10mg
    Each film coated Tablet contains:

    Hydroxyzine Hydrochloride USP……………10mg
    Excipients……………………………………… q. s
    Colours: Titanium Dioxide BP

THERAPEUTIC INDICATIONS:

Hydroxyzine Hydrochloride is indicated to assist in the management of anxiety in adults. Hydroxyzine Hydrochloride is indicated for the management of pruritus associated with acute and chronic urticaria, including cholinergic and physical types, and atopic and contact dermatitis in adults and children.

CAUTION & WARNING:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH
Not suitable for children under 12 years.
Read enclosed leaflet before use.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage: Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).
Store at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature].
Dosage:  As directed by the Physician.

Why Taj Pharmaceuticals?

Why Taj Pharma is your trusted choice for Hydroxyzine HCl Tablets USP – Quality, Expertise, and Patient-Centered Care. Taj Pharma is a leading pharmaceutical company committed to providing high-quality medications that improve lives. Our Hydroxyzine HCl Tablets USP are a testament to our unwavering dedication to excellence in pharmaceuticals. With decades of experience, a global reputation for quality, and a patient-centered approach, Taj Pharma is your partner in achieving better health and well-being. Choose us for Hydroxyzine HCl Tablets USP and experience the difference in pharmaceutical care. Taj Pharma’s Hydroxyzine HCl Tablets USP reflect our commitment to addressing a range of healthcare needs. Hydroxyzine is a versatile medication that serves various purposes, including the management of anxiety, allergy symptoms, and certain skin conditions. Our tablets are meticulously formulated to ensure consistent quality, effectiveness, and patient safety. At Taj Pharma, we understand the importance of patient well-being. Our team of experts works diligently to develop pharmaceutical solutions that make a meaningful difference in people’s lives. Whether it’s providing relief from anxiety-related issues or allergies, our Hydroxyzine HCl Tablets USP are designed to enhance your quality of life.

Moreover, our global presence ensures that individuals around the world have access to our high-quality medications. Taj Pharma’s extensive distribution networks and adherence to international quality standards make us a reliable partner for both healthcare providers and patients. Taj Pharma is the trusted choice for Hydroxyzine HCl Tablets USP because of our unwavering commitment to quality, our dedication to patient well-being, and our global reach. Choose us, and let us be your partner in achieving better health and a higher quality of life through pharmaceutical excellence.

What is Hydroxyzine HCl Tablets USP and its use?

Hydroxyzine HCl Tablets USP contain the active ingredient hydroxyzine hydrochloride, which is an antihistamine with various medical uses. These tablets are formulated to deliver a specific dosage of hydroxyzine hydrochloride and are regulated by the United States Pharmacopeia (USP) standards for quality.

The primary uses of Hydroxyzine HCl Tablets USP include:

  • Anxiety and Tension: Hydroxyzine is often prescribed to manage symptoms of anxiety and tension. It has a calming effect on the central nervous system, which can help reduce feelings of anxiety and promote relaxation.
  • Allergy Relief: Hydroxyzine is an antihistamine, and it can be used to relieve allergy symptoms such as itching, sneezing, runny nose, and skin rash. It is particularly effective for allergic reactions that involve itching.
  • Pruritus (Itching): Hydroxyzine is commonly used to alleviate itching associated with various skin conditions, including eczema, dermatitis, and hives (urticaria).
  • Sedation: Due to its sedative properties, Hydroxyzine may be used as a preoperative medication to induce relaxation and reduce anxiety before surgery.
  • Nausea and Vomiting: In some cases, Hydroxyzine may be used to manage nausea and vomiting, particularly when caused by motion sickness or as an adjunct to other antiemetic (anti-nausea) medications.
  • Insomnia: It may be prescribed off-label for the treatment of insomnia, although it is not a first-line option for this purpose.

It’s important to note that the use of Hydroxyzine should be under the supervision and prescription of a qualified healthcare provider, as the appropriate dosage and duration of treatment can vary depending on the medical condition being treated and the patient’s individual response to the medication. Additionally, Hydroxyzine may cause drowsiness, so individuals taking it should avoid activities that require mental alertness, such as driving, until they know how the medication affects them.

How does Hydroxyzine HCl Tablets USP Work?

Hydroxyzine HCl Tablets USP work primarily by affecting the activity of histamine, a naturally occurring chemical in the body that plays a key role in various physiological processes. Hydroxyzine is an antihistamine, and its mechanism of action involves blocking the effects of histamine. Here’s how it works:

  • Histamine Receptor Blockade: In response to allergens, irritants, or other triggers, the body releases histamine. Histamine binds to specific receptors (H1 receptors) in various tissues, leading to a cascade of responses, including inflammation, itching, increased vascular permeability, and the sensation of itching or allergy symptoms.
  • Antagonism of H1 Receptors: Hydroxyzine works by binding to and blocking these H1 receptors. By doing so, it prevents histamine from binding to these receptors and initiating its effects.
  • Reduction of Allergic Symptoms: By inhibiting the action of histamine at the H1 receptors, Hydroxyzine effectively reduces allergy-related symptoms such as itching, sneezing, runny nose, and skin rashes. This is why it is often used as an antihistamine for allergy relief.
  • Sedative Effect: Hydroxyzine also has a sedative (calming) effect on the central nervous system. It acts as a mild tranquilizer, helping to reduce anxiety and tension. This sedative property makes it useful in the treatment of anxiety and as a preoperative medication to induce relaxation before surgery.
  • Itch Control: Hydroxyzine’s ability to block histamine receptors on the skin and in the central nervous system makes it effective in controlling itching associated with various skin conditions, including eczema, dermatitis, and hives.

Benefits of Hydroxyzine HCl Tablets USP:

  • Allergy Symptom Relief: Hydroxyzine is effective in alleviating allergy symptoms, including itching, sneezing, runny nose, and skin rash. It is often used to provide relief from seasonal allergies and allergic reactions.
  • Anxiety Management: Hydroxyzine has sedative properties that can help manage symptoms of anxiety and tension. It is sometimes prescribed to individuals with generalized anxiety disorder and related conditions to reduce anxiety levels.
  • Itch Control: For various skin conditions such as eczema, dermatitis, and hives, Hydroxyzine is valuable in controlling itching and providing relief from the discomfort associated with these conditions.
  • Preoperative Sedation: Due to its calming effect, Hydroxyzine may be used as a preoperative medication to induce relaxation and reduce anxiety in patients before surgery.
  • Adjunctive Therapy: In some cases, Hydroxyzine may be used as adjunctive therapy in the treatment of conditions like alcohol withdrawal, itching related to renal or liver disease, and nausea and vomiting.

Side Effects of Hydroxyzine HCl Tablets USP:

  • Drowsiness: One of the most common side effects of Hydroxyzine is drowsiness or sedation. This can impair mental alertness and coordination, potentially affecting activities such as driving.
  • Dry Mouth: Dry mouth is a common side effect, which can be managed by staying hydrated and using sugar-free lozenges or gum.
  • Dizziness: Some individuals may experience dizziness, especially when standing up quickly. Changing positions slowly can help minimize this effect.
  • Blurred Vision: Blurred vision or difficulty focusing may occur in some cases.
  • Gastrointestinal Disturbances: Nausea, vomiting, and diarrhea can occur in some individuals, although these side effects are generally less common.
  • Headache: Headaches are another possible side effect, but they are usually mild and transient.
  • Weight Gain: In some cases, Hydroxyzine may be associated with weight gain, although this effect is not common.
  • Skin Reactions: Rarely, allergic skin reactions such as rash or hives may occur.
  • Urinary Retention: Hydroxyzine can affect urinary function and may lead to difficulty in passing urine, particularly in individuals with pre-existing urinary issues.
  • Heart Rate Changes: In rare instances, Hydroxyzine may cause changes in heart rate or rhythm.

Frequently asked questions (FAQs) about Hydroxyzine HCl Tablets USP:

  1. What are Hydroxyzine HCl Tablets USP used for?

These tablets are commonly used to relieve allergy symptoms, manage anxiety, control itching associated with various skin conditions, and induce relaxation before surgery.

  1. How does Hydroxyzine work for anxiety?

Hydroxyzine has a sedative effect on the central nervous system, which helps reduce anxiety and tension. It is often prescribed for anxiety disorders and related conditions.

  1. Is Hydroxyzine habitforming or addictive?

Hydroxyzine is generally not considered habitforming or addictive when used as directed by a healthcare provider. It does not have the same potential for abuse as some other medications used for anxiety.

  1. Can I take Hydroxyzine with other medications?

It’s important to inform your healthcare provider about all medications, supplements, and herbal remedies you are taking, as Hydroxyzine may interact with certain drugs.

  1. How quickly does Hydroxyzine work for anxiety?

The onset of action varies among individuals, but some individuals may start to feel its calming effects within 30 minutes to an hour after taking it.

  1. Does Hydroxyzine cause drowsiness?

Yes, drowsiness is a common side effect of Hydroxyzine. It is important to be cautious when engaging in activities that require mental alertness, such as driving, until you know how the medication affects you.

  1. Can I drink alcohol while taking Hydroxyzine?

It is generally not recommended to consume alcohol while taking Hydroxyzine, as it can intensify the sedative effect and increase the risk of drowsiness and impairment.

  1. Is Hydroxyzine safe during pregnancy and breastfeeding?

Pregnant or breastfeeding individuals should consult their healthcare provider before using Hydroxyzine, as the benefits and risks should be carefully considered.

  1. Can I stop taking Hydroxyzine suddenly?

It is advisable not to stop taking Hydroxyzine abruptly, especially if it has been used for anxiety or other medical conditions. Consult your healthcare provider for guidance on tapering the medication if discontinuation is necessary.

  1. Are there any dietary restrictions with Hydroxyzine?

There are no specific dietary restrictions associated with Hydroxyzine. However, maintaining a healthy diet and lifestyle can support overall wellbeing.

  1. Can Hydroxyzine be given to children?

Hydroxyzine may be prescribed to children in appropriate doses for specific medical conditions, such as allergy relief or itching. The dosage and usage should be determined by a healthcare provider.

As Hydroxyzine HCl Tablets USP Exporters; We can cater to export business queries from the following geographies. We are exporting our Hydroxyzine HCl Tablets USP product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Hydroxyzine HCl Tablets USP Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Hydroxyzine HCl Tablets USP, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274