Promethazine Hydrochloride Tablets Usp

SPL v7

SPL

SPL Set ID 4eaa8291-9cde-4205-857b-925ea8d618ba

Route

ORAL

Published

Effective Date 2024-07-30

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Promethazine (12.5 mg)

Inactive Ingredients

Lactose Monohydrate Magnesium Stearate Hydroxypropyl Cellulose, Unspecified Hydroxypropyl Cellulose, Low Substituted

Identifiers & Packaging

Pill Appearance

Imprint: ZC03 Shape: round Color: white Size: 6 mm Size: 8 mm Size: 10 mm Score: 1

Marketing Status

ANDA Active Since 2005-12-14

Description

NDC 65841-040-01 in bottle of 100 tablets Promethazine Hydrochloride Tablets USP, 12.5 mg R x only 100 tablets NDC 65841-041-01 in bottle of 100 tablets Promethazine Hydrochloride Tablets USP, 25 mg R x only 100 tablets NDC 65841-042-01 in bottle of 100 tablets Promethazine Hydrochloride Tablets USP, 50 mg R x only 100 tablets

Medication Information

Description

Package Label.principal Display Panel

NDC 65841-040-01 in bottle of 100 tablets

Promethazine Hydrochloride Tablets USP, 12.5 mg

R_xonly

100 tablets

NDC 65841-041-01 in bottle of 100 tablets

Promethazine Hydrochloride Tablets USP, 25 mg

R_xonly

100 tablets

NDC 65841-042-01 in bottle of 100 tablets

Promethazine Hydrochloride Tablets USP, 50 mg

R_xonly

100 tablets

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 65841-040-01 in bottle of 100 tablets

Promethazine Hydrochloride Tablets USP, 12.5 mg

R_xonly

100 tablets

NDC 65841-041-01 in bottle of 100 tablets

Promethazine Hydrochloride Tablets USP, 25 mg

R_xonly

100 tablets

NDC 65841-042-01 in bottle of 100 tablets

Promethazine Hydrochloride Tablets USP, 50 mg

R_xonly

100 tablets

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 65841-040-01 in bottle of 100 tablets Promethazine Hydrochloride Tablets USP, 12.5 mg R x only 100 tablets NDC 65841-041-01 in bottle of 100 tablets Promethazine Hydrochloride Tablets USP, 25 mg R x only 100 tablets NDC 65841-042-01 in bottle of 100 tablets Promethazine Hydrochloride Tablets USP, 50 mg R x only 100 tablets"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:44:03.635222 · Updated: 2026-03-14T22:18:33.371936