Hemcalm Tablet
FDA Label NDC 0220-9180

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Hemcalm (NDC 0220-9180). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Otc - Ask Doctor

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Other

→ Inactive Ingredient

→ Otc - Questions

→ Package Label.principal Display Panel

Otc - Active Ingredient

AESCULUS HIPPOCASTANUM 6X HPUS (0.83MG)**
HAMAMELIS VIRGINANA 6X HPUS (0.83MB)**
NUX VOMICA 12X HPUS (0.83MG)** (contains less than 10 ^-13 mg strychnine alkaloids)

Otc - Purpose

AESCULUS HIPPOCASTANUM 6X HPUS REDUCES SWELLING AND RELIEVES STINGING PAIN ASSOCIATED WITH INTERNAL AND EXTERNAL HEMORRHOIDS*

HAMAMELIS VIRGINANA 6X HPUS RELIEVES BURNING, ITCHING, AND DISCOMFORT ASSOCIATED WITH HEMMORRHOIDS*

NUX VOMICA 12X HPUS RELIEVES PAINFUL HEMORRHOIDS ASSOCIATED WITH OVEREATING OR SEDENTARY LIFESTYLES*

(CONTAINS LESS THA 10-13 MG ALKALOIDS)

Indications & Usage

TEMPORARILY RELIEVES SYMPTOMS OF HEMMORRHOIDS SUCH AS: BURNING, ITCHING, SWELLING, PAIN, DISCOMFORT

HELPS SHRINK SWOLLEN HEMORRHOIDS

RELIEVES HEMORRHOID SYMPTOMS FOLLOWING CHILDBIRTH

Otc - Ask Doctor

Ask a doctor before use in case of bleeding

Otc - Stop Use

STOP USE AND ASK A DOCTOR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR WORSEN.

Otc - Pregnancy Or Breast Feeding

IF PREGNANT OR BREASTFEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL 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 2 TABLETS UNDER THE TONGUE EVERY 2 HOURS, UP TO 6 TIMES A DAY.

CHILDREN UNDER 12 YEARS OF AGE: ASK A DOCTOR.

Other

DO NOT USE IF GLUED CARTON AND FLAPS ARE OPEN OR IF THE BLISTER SEAL IS BROKEN

CONTAINS 60 MELTAWAY TABLETS UNFLAVORED

STORE BELOW 86° F (30° C)

*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.

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

Burning, Itching, Pain, Discomfort*

Relieves Internal & External Hemorrhoids*

Plant-Based Actives

No Artificial Colors, Flavors, Sweeteners or Preservatives

Convenient & portable relief

No known drug interactions

Suitable for hemorrhoids following childbirth*