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Ammonium Chloride 138 mg, Diphenhydramine 14.08 mg, Sodium Citrate 57.03 mg / 5 ml Syrup

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Discuss third-party manufacturing with Walter Healthcare, India. Confirm the formulation, syrup presentation, packaging and project requirements for a product-specific quotation.

Catalogue reference
WH-1487
Composition and strength
Ammonium Chloride 138 mg, Diphenhydramine 14.08 mg, Sodium Citrate 57.03 mg / 5 ml
Dosage form
Syrup
Indicative administration route
Oral
Therapeutic navigation area
Respiratory & allergy
Pharmacological class
Antihistamine
Manufacturing stream
Non-beta-lactam

Catalogue details support an initial B2B discussion. Walter confirms the applicable unit, current licence scope, formula, target market and commercial feasibility before making a commitment.

Clinical reference

Mechanism and pharmacokinetics.

Explore the published evidence for the ingredients in Ammonium Chloride 138 mg, Diphenhydramine 14.08 mg, Sodium Citrate 57.03 mg / 5 ml Syrup. Each reference identifies its source formulation and study context. Ingredient studies describe the named reference product; they do not establish the pharmacokinetics, clinical suitability or bioequivalence of this finished formulation.

How to read our product information and sources ↗

Ingredient-level reference

Sodium citrate (oral reference)

Reference for: Sodium Citrate. Source presentation: ORAL SOLUTION. Source route: oral.

Mechanism of action

The reference attributes sodium citrate activity to alkalinity, including its capacity to neutralize gastric acid. This is a physicochemical effect rather than a receptor-specific mechanism.

Pharmacokinetics

The oral-solution reference describes systemic absorption and renal elimination. Sufficient exposure can produce metabolic alkalosis and alkalinization of urine. It does not supply a measured plasma peak time, absolute bioavailability or elimination half-life. These observations concern the cited sodium-citrate solution and do not establish the pharmacokinetics of a cough mixture or another citrate salt.

Ingredient-level summary of the cited reference product. Study formulation, route, strength and population govern interpretation; these data do not establish pharmacokinetics or bioequivalence for Walter's formulation or fixed combination.

Source: Sodium citrate 0.3 M oral solution: SmPC, sections 5.1–5.2

Reference accessed .

Ingredient-level reference

Ammonium chloride (oral combination reference)

Reference for: Ammonium Chloride. Source presentation: COMBINATION SYRUP. Source route: oral.

Mechanism of action

The reference describes reflex stimulation of bronchial secretions through irritant or other chemical properties, reducing mucus viscosity and facilitating clearance.

Pharmacokinetics

Ammonium chloride is readily absorbed from the gastrointestinal tract. Ammonia and ammonium participate in interorgan nitrogen transport; hepatic metabolism forms urea, and urinary elimination predominates. Severe liver or kidney impairment can permit ammonium accumulation. The cited syrup combines ammonium chloride with codeine and diphenhydramine. Its qualitative component information does not provide a half-life or establish the behavior of a different cough formulation.

Ingredient-level summary of the cited reference product. Study formulation, route, strength and population govern interpretation; these data do not establish pharmacokinetics or bioequivalence for Walter's formulation or fixed combination.

Source: South Africa SAHPRA: Benylin Forte Syrup, October 2024, ammonium chloride component

Reference accessed .

Prescribing-label excerpts

Diphenhydramine Hydrochloride

Reference for: Diphenhydramine. Source presentation: solution. Source route: oral.

The source label presents its clinical-pharmacology findings together. These selected passages retain the source’s study context; the full label provides the complete discussion.

Clinical pharmacology

Diphenhydramine hydrochloride is an antihistamine with anticholinergic (drying) and sedative effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells.

A single oral dose of diphenhydramine hydrochloride is quickly absorbed with maximum activity occurring in approximately one hour. The duration of activity following an average dose of diphenhydramine hydrochloride is from four to six hours. Diphenhydramine is widely distributed throughout the body, including the CNS. Little, if any, is excreted unchanged in the urine; most appears as the degradation products of metabolic transformation in the liver, which are almost completely excreted within 24 hours.

Selected passages from the cited U.S. prescribing label. The studies concern the source product and populations named in each passage; they do not establish Walter-product bioequivalence, an approved indication, or the kinetics of another fixed combination. Tables and the full prescribing information remain available in the source.

Source: DailyMed: Diphenhydramine Hydrochloride — solution

Reference accessed . Label revision: 2026-08-03.

Manufacturing & packaging brief

Plan the syrup presentation.

Use this preparation guide for Ammonium Chloride 138 mg, Diphenhydramine 14.08 mg, Sodium Citrate 57.03 mg / 5 ml Syrup. These are the decisions to resolve with the technical team before a site, process and commercial scope are confirmed.

Presentation & formulation

Specify the ingredient amounts per stated volume and the separate bottle fill volume. Identify flavour, colour and ingredient exclusions as requirements for review.

Quality & technical transfer

Agree the formula, analytical methods and applicable physical and microbiological specifications. Confirm the basis for any proposed storage or label statement.

Review the technical documents

Packaging configuration

Describe the bottle, closure and measuring cup, spoon or syringe. Ask for the container and measuring accessory to be assessed with the formulation.

Explore packaging options

Details to confirm for this record

Full composition
Keep all named components and their individual amounts together in the specification. Ingredient substitutions, omissions and changed ratios require a separate formula and permission review.
Salt and strength wording
Confirm whether the stated amount refers to the named salt, hydrate or equivalent active moiety. Use the agreed expression consistently in the specification, quotation and artwork.
Concentration and pack size
The record includes a concentration or percentage expression. Confirm its complete basis, then specify the finished fill volume or weight separately. Do not treat pack size as the strength.

Quantities, MOQ & lead time

For Ammonium Chloride 138 mg, Diphenhydramine 14.08 mg, Sodium… Syrup (WH-1487), state the bottle count and fill volume, target market and reorder forecast. MOQ and lead time depend on the assessed formula, process, components, testing and project readiness; request those terms in writing.

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Explore the context

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Related catalogue records

Grouped by catalogue navigation labels, not by therapeutic interchangeability or clinical recommendation.

Common questions

Before you request a quotation.

Ammonium Chloride 138 mg, Diphenhydramine 14.08 mg, Sodium Citrate 57.03 mg / 5 ml Syrup

What is listed in the catalogue?

The catalogue lists Ammonium Chloride 138 mg, Diphenhydramine 14.08 mg, Sodium Citrate 57.03 mg / 5 ml as syrup in its respiratory & allergy navigation area and non-beta-lactam manufacturing stream.

Is manufacturing availability confirmed?

No. Walter checks current facility permissions, formulation and equipment fit, testing, packaging and target-market requirements before written confirmation.

What do I need for a quotation?

Share the exact composition and strength, syrup presentation, target market, initial quantity, preferred pack and timing. Identify whether this is a new product, development brief or transfer.

The quotation must confirm MOQ, inclusions, prerequisites and lead time for the proposed product and site.

Can I change the pack or target market?

Include each proposed pack and country in the enquiry. Container compatibility, artwork, supporting stability evidence, permission scope and destination requirements need review for the requested configuration.

A catalogue record does not establish export registration or a shelf-life commitment.

How do I submit my enquiry?

Use the product-specific enquiry button to carry this composition and dosage form into the form. After a successful submission, a receipt reference confirms that your brief has been saved for review. Use the RFQ checklist to prepare the remaining details.

Technical document review

Which documents can I ask Walter to review?

Ask about manufacturing and packing records, specifications, analytical methods, Certificates of Analysis (COA), stability evidence, the Process Validation Protocol (PVP) and Process Validation Report (PVR). The wider checklist below covers supplier qualification, technical transfer and ongoing supply.

View the full document checklist 14 review areas
Site, licence and audit scope
Manufacturing licence, applicable product permissions, GMP certificates, Site Master File, supplier-qualification questionnaire and relevant audit responses.
Manufacturing, packing and batch release
Master Formula Record (MFR), master packing instructions, Batch Manufacturing Record (BMR), Batch Packing Record (BPR), reconciliation and authorised release records.
Process validation and continued verification
Process Validation Protocol (PVP), Process Validation Report (PVR), process performance qualification documents and continued process verification trends.
Equipment, facilities and utilities
Validation Master Plan (VMP), user requirements, DQ/IQ/OQ/PQ records, calibration and maintenance evidence for relevant equipment and utilities.
Cleaning, carryover and hold times
Cleaning Validation Protocol (CVP), Cleaning Validation Report (CVR), residue limits, recovery studies and applicable clean, dirty and process hold-time studies.
Specifications and analytical evidence
Specifications, Method of Analysis (MOA), Standard Testing Procedure (STP), Certificates of Analysis (COA), analytical validation, verification and method-transfer records.
Stability, packaging and transport
Stability protocols/reports, ongoing stability commitments, pack specifications, approved artwork, compatibility and applicable packaging or transport studies.
Development and technology transfer
Development report, technology-transfer protocol/report, gap assessment, control strategy, critical quality attributes and critical process parameters.
Quality reviews, investigations and changes
Product Quality Review (PQR) / Annual Product Review (APR), deviations, CAPA, change control, OOS/OOT trends, complaints, recalls and relevant SOP/training records.
Material suppliers and impurity risks
API/excipient supplier qualification, traceability, material COAs, relevant origin declarations and impurity risk assessments with supporting tests.
Sterile-product evidence, where applicable
Contamination Control Strategy (CCS), media-fill/aseptic simulation reports, sterilisation and filtration validation, environmental monitoring, sterility/endotoxin and container-closure integrity evidence.
Computerised systems and data integrity
Computerised-system validation, access controls, audit-trail review, backup/restore checks and relevant data-integrity procedures.
Market-specific regulatory support
Applicable dossier sections, API master-file/CEP support, bioequivalence or biowaiver evidence and Certificate of a Pharmaceutical Product (CPP/CoPP), where required and available.
Quality agreement and access arrangements
Quality/technical agreement covering responsibilities, release, changes, subcontracting, investigations, complaints, recalls, audits and document access.

Agree the list for the exact product, site, process, pack, market and project stage. QA confirms what exists, applies and may be shared; some records may require an NDA, redaction or controlled review. See document definitions and review guidance.

Important qualification

This B2B catalogue record is not proof of current approval or confirmation that Ammonium Chloride 138 mg, Diphenhydramine 14.08 mg, Sodium Citrate 57.03 mg / 5 ml Syrup is available for sale. It is not prescribing information or patient advice. Any Drugs Rules status, current approval, exemption, applicable unit, licence scope, formulation, claims, brand use, destination-market registration and commercial feasibility require documentary verification and Walter's written confirmation. Read the full regulatory disclaimer.

Composition and classification are taken from Walter's product catalogue. The manufacturing guide helps buyers prepare a technical brief. Clinical references, where shown, describe the cited product and study. Manufacturing guide updated .