COLDCALM- onion, apis mellifera, atropa belladonna, eupatorium perfoliatum flowering top, gelsemium sempervirens root, potassium dichromate, strychnos nux-vomica seed, phytolacca americana root, pulsatilla vulgaris whole pellet

COLDCALM by

Drug Labeling and Warnings

COLDCALM 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 ingredients** (in each pellet)

Allium cepa 3C HPUS (0.05 mg)

Apis mellifica 6C HPUS (0.05 mg)

Belladonna 6C HPUS (0.05 mg)(contains less than 10 -15 mg atropine alkaloids)

Eupatorium perfoliatum 3C HPUS (0.05 mg)

Gelsemium sempervirens 6C HPUS (0.05 mg)

Kali bichromicum 6C HPUS (0.05 mg)

Nux vomica 3C HPUS (0.05 mg) (contains less than 10 -8 mg strychnine alkaloids)

Phytolacca decandra 6C HPUS (0.05 mg)

Pulsatilla 6C HPUS (0.05 mg)

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

PURPOSE

Purpose*

Relieves Cold Symptoms: Sneezing, Runny Nose, Occasional Minor Sore Throat, and Congestion

INDICATIONS & USAGE

Uses*

temporarily relieves cold symptoms such as:

▪ sneezing ▪ runny nose ▪ nasal congestion ▪ occasional minor sore throat t

WARNINGS

Do not use if you are allergic to Apis.

ASK DOCTOR

Ask a doctor before use if sore throat is severe, accompanied or followed by fever, headache, rash, nausea, or vomiting.

STOP USE

Stop use and ask a doctor if ▪ sore throat worsens or persists for more than 2 days ▪ nasal congestion worsens or lasts more than 5 days in children under 12 years of age or 7 days in adults ▪ new symptoms occur

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, 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

Directions

• Adults and children 4 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every 15 minutes for 1 hour. Then, dissolve 5 pellets under the tongue every 6 hours. Decrease frequency with improvement.
  
• Children under 4 years of age: Ask a doctor.

SPL UNCLASSIFIED SECTION

Other information

• 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

INACTIVE INGREDIENT

lactose, sucrose

QUESTIONS

Questions or comments?

1-800-264-7661

Made in France

Distributed by

Boiron Inc.

Newtown Square, PA

19073

SPL UNCLASSIFIED SECTION

2 PORTABLE TUBES

APPROX. 80 PELLETS EACH

TOTAL 160 PELLETS

Multi-Symptom Cold Relief*

No Known Drug Interactions

*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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLDCALM 
onion, apis mellifera, atropa belladonna, eupatorium perfoliatum flowering top, gelsemium sempervirens root, potassium dichromate, strychnos nux-vomica seed, phytolacca americana root, pulsatilla vulgaris whole pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9098
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	6 [hp_C]
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	6 [hp_C]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_C]
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	3 [hp_C]
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_C]
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	6 [hp_C]
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	3 [hp_C]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_C]
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	3 [hp_C]

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

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: 0220-9098-42	2 in 1 BOX	03/15/2022
1	NDC: 0220-9098-41	80 in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0220-9098-41	80 in 1 TUBE; Type 0: Not a Combination Product	03/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/15/2022

Labeler - Boiron (282560473)

Registrant - Boiron, Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9098)