Plantago Primula

Manufacturer: Uriel Pharmacy, Inc.
Effective date: 2023-10-05
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:22:29

Label at a glance#

ProductPlantago Primula

Active ingredientPLANTAGO MAJOR LEAF, PRIMULA VERIS FLOWER, HYOSCYAMUS NIGER LEAF

Label structure9 sections

Contacts and useful links#

PhoneLabel contact866.642.2858

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Take 3-4 times daily. Ages 12 and older: 10 drops. Ages 2-11: 5 drops. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: 100 gm contains: 2.5 gm Plantago (Ribwort plantain) 1X, 2.5gm Primula (Cowslip) 1X, 0.1 gm Hyoscyamus (Henbane) 4X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Distilled water, 20% Organic cane alcohol

OTC - PURPOSE SECTION

Use: Temporary relief of headache.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
shopuriel.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Plantago Primula Liquid

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
48951-8400-3	Plantago Primula	60 mL in 1 BOTTLE, DROPPER	LIQUID	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
48951-8400	PLANTAGO PRIMULA LIQUID [URIEL PHARMACY, INC.]	1	1 package rows	20231006_06fb73a5-10fb-1a7a-e063-6394a90a9809.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Plantago Primula
WATER
PLANTAGO MAJOR LEAF
PRIMULA VERIS FLOWER
HYOSCYAMUS NIGER LEAF
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
48951-8400	48951-8400-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
PLANTAGO MAJOR LEAF	7DC28K241X	ACTIB
PRIMULA VERIS FLOWER	W5BET37294	ACTIB
HYOSCYAMUS NIGER LEAF	32IT7G8BAW	ACTIB
ALCOHOL	3K9958V90M	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
06fb73a5-10fc-1a7a-e063-6394a90a9809			06fb73a5-10fb-1a7a-e063-6394a90a9809	2023-10-05	Warnings	Exact identifier spl id: 06fb73a5-10fc-1a7a-e063-6394a90a9809 spl set id: 06fb73a5-10fb-1a7a-e063-6394a90a9809

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.