Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID bc92de6c-f35a-49e8-9540-749197aebdba
Route
ORAL
Published
Effective Date 2023-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sarsaparilla (4 [hp_X]) Berberis Vulgaris Root Bark (6 [hp_X]) Leonurus Cardiaca (12 [hp_X]) Lycopodium Clavatum Spore (30 [hp_X]) Nitric Acid Digitalis Oxalic Acid Uric Acid
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-08-23

Description

Sarsaparilla 4X, Berberis Vulgaris 6X, Leonurus Cardiaca 6X, Lycopodium Clavatum 6X, Nitricum Acidum 6X, Digitalis Purpurea 12X, Oxalicum Acidum 30X, Uricum Acidum 30X.

Purpose

Aids in temporary relief of Pain in abdomen extending to the side or back, frequent and urgent need to urinate, and sensation of urine remaining after urinating.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Aids in temporary relief of Pain in abdomen extending to the side or back, frequent and urgent need to urinate, and sensation of urine remaining after urinating.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Sarsaparilla 4X, Berberis Vulgaris 6X, Leonurus Cardiaca 6X, Lycopodium Clavatum 6X, Nitricum Acidum 6X, Digitalis Purpurea 12X, Oxalicum Acidum 30X, Uricum Acidum 30X.

Purpose:

Aids in temporary relief of Pain in abdomen extending to the side or back, frequent and urgent need to urinate, and sensation of urine remaining after urinating.†

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

Warnings:

Professional Use Only

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

Questions:

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

Directions:

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

Indications:

Aids in temporary relief of Pain in abdomen extending to the side or back, frequent and urgent need to urinate, and sensation of urine remaining after urinating.†

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

Active Ingredients:

Sarsaparilla 4X, Berberis Vulgaris 6X, Leonurus Cardiaca 6X, Lycopodium Clavatum 6X, Nitricum Acidum 6X, Digitalis Purpurea 12X, Oxalicum Acidum 30X, Uricum Acidum 30X.

Inactive Ingredients:

Alcohol USP 20%, Purified Water USP.

Package Label Display:

Professional

Health Products

HOMEOPATHIC

NDC 83027-0102-1

RENAL HEALTH

FORMULA

2 FL. OZ (60 ml)

Keep Out of Reach of Children:

In case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Purpose: (PURPOSE:)

Aids in temporary relief of Pain in abdomen extending to the side or back, frequent and urgent need to urinate, and sensation of urine remaining after urinating.†

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

Warnings: (WARNINGS:)

Professional Use Only

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

Questions: (QUESTIONS:)

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

Directions: (DIRECTIONS:)

Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

Aids in temporary relief of Pain in abdomen extending to the side or back, frequent and urgent need to urinate, and sensation of urine remaining after urinating.†

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

Active Ingredients: (ACTIVE INGREDIENTS:)

Sarsaparilla 4X, Berberis Vulgaris 6X, Leonurus Cardiaca 6X, Lycopodium Clavatum 6X, Nitricum Acidum 6X, Digitalis Purpurea 12X, Oxalicum Acidum 30X, Uricum Acidum 30X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alcohol USP 20%, Purified Water USP.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Professional

Health Products

HOMEOPATHIC

NDC 83027-0102-1

RENAL HEALTH

FORMULA

2 FL. OZ (60 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

In case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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