Hemcalm

Hemcalm
SPL v5
SPL
SPL Set ID 8f8c295f-b6ec-6c6f-e053-2995a90aad9e
Route
ORAL
Published
Effective Date 2024-02-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hamamelis Virginiana Root Bark/stem Bark (6 [hp_X]) Strychnos Nux-vomica Seed (12 [hp_X]) Horse Chestnut
Inactive Ingredients
Anhydrous Lactose Magnesium Stearate Croscarmellose

Identifiers & Packaging

Pill Appearance
Imprint: BOIRON Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-12-01

Description

Active ingredients** Aesculus hippocastanum 6X HPUS (0.83 mg) Hamamelis virginiana 6X HPUS (0.83 mg) Nux vomica 12X HPUS (0.83 mg) (contains less than 10 -13 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

Indications and Usage

Uses *

temporarily relieves symptoms of hemorrhoids such as:

  • burning
  • itching
  • swelling
  • pain
  • discomfort

  • temporarily shrinks hemorrhoidal tissue
  • relieves hemorrhoid symptoms following childbirth

Dosage and Administration

Adults and children 12 years of age and older: At the onset of symptoms, dissolve 2 tablets in the mouth every 2 hours, up to 6 times a day.

Children under 12 years of age: Ask a doctor.

Description

Active ingredients** Aesculus hippocastanum 6X HPUS (0.83 mg) Hamamelis virginiana 6X HPUS (0.83 mg) Nux vomica 12X HPUS (0.83 mg) (contains less than 10 -13 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 the blister seal is broken

60 MELTAWAY TABLETS Unflavored

store below 86° F (30° C)

Hemorrhoid Relief*

Burning, Itching, Pain, Discomfort*

Relieves Internal & External Hemorrhoids*

Plant-Powered Relief

No known drug interactions

Suitable for hemorrhoids following childbirth*

*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

croscarmellose sodium, lactose, magnesium stearate

Section 51945-4

Section 53413-1

1-800-BOIRON-1 (1-800-264-7661)

BoironUSA.com [email protected]

Distributed by Boiron, Inc. Newtown Square, PA 19073

Section 53414-9

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

Section 55105-1

Purpose*

Aesculus hippocastanum 6X HPUS (0.83 mg) ... Relieves swelling and relieves stinging pain associated with internal and external hemorrhoids

Hamamelis virginiana 6X HPUS (0.83 mg) ... Relieves burning, itching, and discomfort associated with hemorrhoids

Nux vomica 12X HPUS (0.83 mg) ... Relieves painful hemorrhoids associated with overeating and sedentary lifestyles

Section 55106-9

Active ingredients**

Aesculus hippocastanum 6X HPUS (0.83 mg)

Hamamelis virginiana 6X HPUS (0.83 mg)

Nux vomica 12X HPUS (0.83 mg) (contains less than 10 -13 mg strychnine alkaloids)

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


Structured Label Content

Indications and Usage (34067-9)

Uses *

temporarily relieves symptoms of hemorrhoids such as:

  • burning
  • itching
  • swelling
  • pain
  • discomfort

  • temporarily shrinks hemorrhoidal tissue
  • 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 2 tablets in the mouth 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 the blister seal is broken

60 MELTAWAY TABLETS Unflavored

store below 86° F (30° C)

Hemorrhoid Relief*

Burning, Itching, Pain, Discomfort*

Relieves Internal & External Hemorrhoids*

Plant-Powered Relief

No known drug interactions

Suitable for hemorrhoids following childbirth*

*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)

croscarmellose sodium, lactose, magnesium stearate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-800-BOIRON-1 (1-800-264-7661)

BoironUSA.com [email protected]

Distributed by Boiron, Inc. Newtown Square, PA 19073

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose*

Aesculus hippocastanum 6X HPUS (0.83 mg) ... Relieves swelling and relieves stinging pain associated with internal and external hemorrhoids

Hamamelis virginiana 6X HPUS (0.83 mg) ... Relieves burning, itching, and discomfort associated with hemorrhoids

Nux vomica 12X HPUS (0.83 mg) ... Relieves painful hemorrhoids associated with overeating and sedentary lifestyles

Section 55106-9 (55106-9)

Active ingredients**

Aesculus hippocastanum 6X HPUS (0.83 mg)

Hamamelis virginiana 6X HPUS (0.83 mg)

Nux vomica 12X HPUS (0.83 mg) (contains less than 10 -13 mg strychnine alkaloids)

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


Advanced Ingredient Data


Raw Label Data

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