Promethazine Hydrochloride
12.5 mg · Tablet
- Prescription only
- Phenothiazine
- Active substance
- Promethazine Hydrochloride
- Made by
- Zydus Lifesciences Limited
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
This information is not included in the verified source. Open the official leaflet
How it works
From the US prescribing label for the same active substance (Promethazine). It describes the substance, not this exact product.
Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution.
It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties.
Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N- demethylpromethazine are the predominant metabolites appearing in the urine.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2022-10-08
Safety of the active substance
From the US prescribing label for the same active substance (Promethazine). It describes the substance, not this exact product.
- Promethazine hydrochloride tablets, USP are contraindicated for use in pediatric patients less than two years of age.
- Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
Details
| Made by | Zydus Lifesciences Limited |
|---|---|
| Active substance | Promethazine Hydrochloride |
| Used in | Pain, sleep, mood, epilepsy and the brain |
| Strength | 12.5 mg |
| Form | Tablet |
| Route | Oral |
| Packs | 100 TABLET in 1 BOTTLE · 500 TABLET in 1 BOTTLE |
| NDC | 65841-040 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
83 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Tablet53 products
- Injection8 products
50 mg/mL3
50 mg/mL · 3 companies
- Suppository8 products
12.5 mg3
12.5 mg · 3 companies
- Solution6 products
Show all forms · 6 forms
- Syrup5 products
6.25 mg/5mL5
- Injection, Solution3 products
25 mg/mL2
25 mg/mL · 2 companies
- 50 mg/mL
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.