hemcalm pellets

hemcalm pellets
SPL v2
SPL
SPL Set ID dea9bd55-8e08-2165-e053-2995a90a8e81
Route
oral
Published
Effective Date 2022-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
strychnos nux-vomica seed (12 [hp_X]) horse chestnut (6 [hp_X]) hamamelis virginiana root bark/stem bark
Inactive Ingredients
lactose, unspecified form sucrose

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 4 mm
Marketing Status
unapproved homeopathic active Since 2022-05-10

Description

Active Ingredient** (in each pellet) Aesculus hippocastanum 6X HPUS (0.15 mg) Hamamelis virginiana 6X HPUS (0.15 mg) Nux Vomica 12X HPUS (0.15 mg) (contains less than 10-14 mg strychnine alkaloids) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Medication Information

Active Ingredient

Active Ingredient** (in each pellet)

Aesculus hippocastanum 6X HPUS (0.15 mg)

Hamamelis virginiana 6X HPUS (0.15 mg)

Nux Vomica 12X HPUS (0.15 mg) (contains less than 10-14 mg strychnine alkaloids)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Indications and Usage

Uses*

  • temporarily relieves symptoms of internal and external hemorrhoids such as:
  • burning
  • itching
  • swelling
  • pain
  • discomfort
  • helps shrink swollen hemorrhoids
  • relieves hemorrhoid symptoms following childbirth
Dosage and Administration
  • Adults and children 12 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every 2 hours, up to 6 times a day.
  • Children under 12 years of age: Ask a doctor.
Description

Active Ingredient** (in each pellet) Aesculus hippocastanum 6X HPUS (0.15 mg) Hamamelis virginiana 6X HPUS (0.15 mg) Nux Vomica 12X HPUS (0.15 mg) (contains less than 10-14 mg strychnine alkaloids) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 42229-5
  • do not use if glued carton end flaps are open or if pellet dispenser seal is broken
  • contains 0.25 g of sugar per dose

Hemorrhoid Relief*

Internal & External Hemorrhoids

Relieves Burning, Itching & Pain*

2 PORTABLE TUBES

APPROX. 80 PELLETS EACH

TOTAL 160 PELLETS

Contains 80 pellets, 3.8 g (0.13 oz)

Turn tube upside down, Twist until 5 pellets are dispensed, Remove cap and pour pellets under the tongue

Do not use if pellet dispenser seal is broken.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.

Section 50569-3

Ask a doctor before use in case of bleeding.

Section 51727-6

lactose, sucrose

Section 51945-4

Section 53413-1

BoironUSA.com

[email protected]

1-800-264-7661

Made in France

Distributed by

Boiron, Inc.

Newtown Square, PA

19073

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

Purpose*

Relieves Symptoms of Internal & External Hemorrhoids: Burning, Itching, Pain, and Swelling


Structured Label Content

Active Ingredient (55106-9)

Active Ingredient** (in each pellet)

Aesculus hippocastanum 6X HPUS (0.15 mg)

Hamamelis virginiana 6X HPUS (0.15 mg)

Nux Vomica 12X HPUS (0.15 mg) (contains less than 10-14 mg strychnine alkaloids)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Indications and Usage (34067-9)

Uses*

  • temporarily relieves symptoms of internal and external hemorrhoids such as:
  • burning
  • itching
  • swelling
  • pain
  • discomfort
  • helps shrink swollen hemorrhoids
  • relieves hemorrhoid symptoms following childbirth
Dosage and Administration (34068-7)
  • Adults and children 12 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every 2 hours, up to 6 times a day.
  • Children under 12 years of age: Ask a doctor.
Section 42229-5 (42229-5)
  • do not use if glued carton end flaps are open or if pellet dispenser seal is broken
  • contains 0.25 g of sugar per dose

Hemorrhoid Relief*

Internal & External Hemorrhoids

Relieves Burning, Itching & Pain*

2 PORTABLE TUBES

APPROX. 80 PELLETS EACH

TOTAL 160 PELLETS

Contains 80 pellets, 3.8 g (0.13 oz)

Turn tube upside down, Twist until 5 pellets are dispensed, Remove cap and pour pellets under the tongue

Do not use if pellet dispenser seal is broken.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.

Section 50569-3 (50569-3)

Ask a doctor before use in case of bleeding.

Section 51727-6 (51727-6)

lactose, sucrose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

BoironUSA.com

[email protected]

1-800-264-7661

Made in France

Distributed by

Boiron, Inc.

Newtown Square, PA

19073

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose*

Relieves Symptoms of Internal & External Hemorrhoids: Burning, Itching, Pain, and Swelling


Advanced Ingredient Data


Raw Label Data

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