Description

Doxylamine Succinate Film-Coated Tablets (25 mg)

Healthy Inc is a specialized global supplier and exporter of advanced CNS therapeutics, non-prescription sleep aids, and targeted antihistamine formulations. We provide ultra-high-purity, kinetically optimized Doxylamine Succinate Film-Coated Tablets (25 mg), manufactured in WHO–GMP certified, high-capacity, automated oral solid dosage facilities. This “First-Generation Central H1-Receptor Antagonist” is a massive-volume, highly lucrative export to major pharmacy chains, OTC distributors, sleep clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally preferred, non-narcotic intervention for the short-term management of insomnia and severe sleep-onset latency.

Product Overview

This highly advanced formulation operates as a profound, centralized neurological dampener. Unlike modern allergy pills that are designed to stay out of the brain, Doxylamine is intentionally engineered to violently cross the blood-brain barrier, shutting down the brain’s primary wakefulness chemical to force the onset of sleep.

The “Blood-Brain Barrier Penetrator & Non-Habit Hypnotic” Specialist:

• Mechanism 1 (The Central H1 Blockade): In the human brain, the tuberomammillary nucleus releases histamine to keep the cerebral cortex awake, alert, and aroused. Doxylamine is a highly lipophilic ethanolamine-class antihistamine. It rapidly breaches the blood-brain barrier and acts as an inverse agonist at these central H1 receptors. By blocking the histamine wakefulness signal, it instantly depresses central nervous system activity, drastically reducing the time it takes for a patient to fall asleep.
• Mechanism 2 (The Anticholinergic Sedation Cascade): Beyond histamine, Doxylamine is a potent antagonist of central muscarinic acetylcholine receptors. This heavy anticholinergic action provides a powerful secondary wave of sedation, physically relaxing the patient while simultaneously drying up respiratory secretions (making it highly effective in night-time cold/cough formulations).
• The “Regulatory Frictionless” Advantage: Because it works via the histamine pathway rather than the GABA pathway (like Benzodiazepines or Z-drugs), Doxylamine does not cause physical addiction, tolerance, or dangerous withdrawal seizures. It is globally classified as a non-controlled OTC substance, allowing massive bulk container shipments across international borders without the crippling delays of narcotic export permits.

Product Composition & Strength

We supply this product as a Precision-Blended, Rapid-Release Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the succinate salt.

*Pack Sizes: 10×10 Blisters or Bottles of 30/100 (Optimized specifically for high-volume, over-the-counter retail distribution).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, OTC Wholesale Distributors, and Retail Pharmacy Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Rapid-Release Disintegration & Taste-Masking (CRITICAL COMPLIANCE): The commercial success of an OTC sleep aid relies entirely on patient experience. If the pill tastes terrible or takes two hours to work, the consumer will never buy it again. Our high-speed commercial suites utilize elite superdisintegrants (Sodium Starch Glycolate) combined with specialized aqueous film-coating. This locks the bitter API away from the patient’s taste buds but guarantees violent expansion and dissolution upon contact with gastric acid, delivering a 30-minute sleep onset profile.

Therapeutic Indications (Human Use)

Indicated for the targeted, rapid management of sleep disruption and allergic conditions:

• Short-Term Insomnia: Relief of transient insomnia, sleep-onset latency, and difficulty staying asleep.
• Night-Time Cold & Cough (Combination Use): Often co-administered with antitussives or decongestants to relieve severe nighttime upper respiratory symptoms and induce rest.
• Nausea and Vomiting of Pregnancy (NVP): (Often utilized at lower doses in combination with Pyridoxine/Vitamin B6 as the global gold standard for morning sickness).

Dosage & Administration

Recommended Dosage (Strictly as per Product Guidelines):

• Standard Adult Dosing: 25 mg taken orally 30 minutes before bedtime.
• Administration: Must be taken with a glass of water. The patient should only take this medication if they have a full 7 to 8 hours dedicated to sleep to avoid severe morning impairment.
• Duration of Use: Should not be used consecutively for more than two weeks unless directed by a physician, to prevent anticholinergic tolerance.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• The “Next-Day Hangover” Effect: Doxylamine has a relatively long half-life (approx. 10 hours). Patients must be explicitly warned of severe residual daytime drowsiness, “brain fog,” and impaired motor skills the morning after use. Driving or operating heavy machinery is dangerous until the drug fully clears.
• Glaucoma & BPH Contraindication: Because of its massive anticholinergic activity, Doxylamine will dilate the pupils and contract the urinary sphincter. It is strictly contraindicated in patients with narrow-angle glaucoma or older men with Benign Prostatic Hyperplasia (BPH), as it can trigger acute blindness or acute urinary retention.
• Fatal Pediatric Overdose (CNS Paradox): In young children, high doses of first-generation antihistamines cause a “paradoxical reaction”—instead of sleep, it triggers severe central nervous system excitation, violent seizures, and potentially fatal cardiac arrest. Keep strictly out of reach of children.
• Alcohol & Depressant Interaction: Co-administration with alcohol, opioids, or benzodiazepines violently multiplies the central nervous system depression, leading to dangerous respiratory depression.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and OTC Retail Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antihistamines, OTC Sleep Aids, and Rapid-Release Formulations. Whether you are looking for a reliable Volume Supplier for pharmacy chains in the CIS or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, legally frictionless delivery of WHO-GMP certified products.