HEMCALM- horse chestnut, hamamelis virginiana root bark/stem bark, strychnos nux-vomica seed pellet

HEMCALM by

Drug Labeling and Warnings

HEMCALM by is a Homeopathic medication manufactured, distributed, or labeled by Boiron, Boiron, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PURPOSE

Purpose*

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

INDICATIONS & 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

WARNINGS

ASK DOCTOR

Ask a doctor before use in case of bleeding.

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

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.

DOSAGE & 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.

SPL UNCLASSIFIED SECTION

• 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.

INACTIVE INGREDIENT

lactose, sucrose

QUESTIONS

BoironUSA.com

Info@Boiron.com

1-800-264-7661

Made in France

Distributed by

Boiron, Inc.

Newtown Square, PA

19073

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEMCALM 
horse chestnut, hamamelis virginiana root bark/stem bark, strychnos nux-vomica seed pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9181
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	12 [hp_X]
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ)	HORSE CHESTNUT	6 [hp_X]
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white	Score
Shape	ROUND	Size	4mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9181-42	2 in 1 BOX	05/10/2022
1	NDC: 0220-9181-41	80 in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/10/2022

Labeler - Boiron (282560473)

Registrant - Boiron, Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9181)