1a352e5d-c243-6409-e063-6294a90a4811

SPL v1

SPL

SPL Set ID 1a352e5d-c243-6409-e063-6294a90a4811

Route

oral

Published

Effective Date 2024-05-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

kalmia latifolia leaf (3 [hp_X])

Inactive Ingredients

alcohol water

Identifiers & Packaging

Marketing Status

unapproved homeopathic active Since 2024-05-23

Description

KALMIA LAT HPUS 3X and higher

Medication Information

Warnings

This product is to be used for self-limiting conditions

Uses

USES: Temporary Relief - Headache*

* Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Inactive Ingredients

Active: As Above; Inactive: ENA 50% v/v and Purified Water q.s.

Description

KALMIA LAT HPUS 3X and higher

Dosage

Adults: Mix 4-6 drops in 1/2 cup of water, take orally three times daily or as directed by a physician. Children (2 years and older): Take half the adult dose.

Section 50565-1

Keep this and all medication out of reach of children

Section 50566-9

If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

Section 50570-1

Do not use if capseal is broken or missing.

Close the cap tightly after use.

Section 51945-4

Section 53414-9

As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product

Storage

Store in a cool dark place

Indications

Condition listed above or as directed by the physician

Active Ingredient

KALMIA LAT HPUS 3X and higher

Questions Or Comments

www.Rxhomeo.com | 1.888.2796642 | [email protected] - Rxhomeo, Inc 2940 Eisenhower St., Suite 100, Carrollton, TX 75007 USA

Structured Label Content

Warnings (WARNINGS)

This product is to be used for self-limiting conditions

Uses (USES)

USES: Temporary Relief - Headache*

* Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Inactive Ingredients (INACTIVE INGREDIENTS)

Active: As Above; Inactive: ENA 50% v/v and Purified Water q.s.

Dosage (DOSAGE)

Adults: Mix 4-6 drops in 1/2 cup of water, take orally three times daily or as directed by a physician. Children (2 years and older): Take half the adult dose.

Section 50565-1 (50565-1)

Keep this and all medication out of reach of children

Section 50566-9 (50566-9)

If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

Section 50570-1 (50570-1)

Do not use if capseal is broken or missing.

Close the cap tightly after use.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product

Storage (STORAGE)

Store in a cool dark place

Indications (INDICATIONS)

Condition listed above or as directed by the physician

Active Ingredient (ACTIVE INGREDIENT)

KALMIA LAT HPUS 3X and higher

Questions Or Comments (QUESTIONS OR COMMENTS)

www.Rxhomeo.com | 1.888.2796642 | [email protected] - Rxhomeo, Inc 2940 Eisenhower St., Suite 100, Carrollton, TX 75007 USA

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "KALMIA LATIFOLIA LEAF", "unii": "79N6542N18", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"USES": "USES: Temporary Relief - Headache* * Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.", "DOSAGE": "Adults: Mix 4-6 drops in 1/2 cup of water, take orally three times daily or as directed by a physician. Children (2 years and older): Take half the adult dose.", "50565-1": "Keep this and all medication out of reach of children", "50566-9": "If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional", "50570-1": "Do not use if capseal is broken or missing. Close the cap tightly after use.", "53414-9": "As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product", "STORAGE": "Store in a cool dark place", "WARNINGS": "This product is to be used for self-limiting conditions", "INDICATIONS": "Condition listed above or as directed by the physician", "ACTIVE INGREDIENT": "KALMIA LAT HPUS 3X and higher", "INACTIVE INGREDIENTS": "Active: As Above; Inactive: ENA 50% v/v and Purified Water q.s.", "QUESTIONS OR COMMENTS": "www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com - Rxhomeo, Inc 2940 Eisenhower St., Suite 100, Carrollton, TX 75007 USA"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:30.784738 · Updated: 2026-03-14T23:16:55.652275