Coldcalm: Homeopathic Product Information

COLDCALM- onion, apis mellifera, eupatorium perfoliatum flowering top, gelsemium sempervirens root, potassium dichromate, strychnos nux-vomica seed, phytolacca americana root and pulsatilla vulgaris liquid
Laboratoires Boiron

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Active Ingredients

Active ingredients** (in each vial)

Allium cepa 3C HPUS (0.125 mL)

Apis mellifica 15C HPUS (0.125 mL)

Eupatorium perfoliatum 3C HPUS (0.125 mL)

Gelsemium sempervirens 6C HPUS (0.125 mL) (contains less than 10 ^-11 mg gelsemine alkaloids)

Kali bichromicum 6C HPUS (0.125 mL) (contains less than 10 ^-10 mg chromium)

Nux vomica 3C HPUS (0.125 mL) (contains less than 10 ^-5 mg strychnine alkaloids)

Phytolacca decandra 6C HPUS (0.125 mL)

Pulsatilla 6C HPUS (0.125 mL)

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

Purpose

Purpose*

Allium cepa 3C HPUS … Relieves sneezing and runny nose
Apis mellifica 15C HPUS … Relieves nasal congestion
Eupatorium perfoliatum 3C HPUS … Relieves body aches associated with colds
Gelsemium sempervirens 6C HPUS … Relieves headaches associated with colds
Kali bichromicum 6C HPUS … Relieves nasal discharge
Nux vomica 3C HPUS … Relieves sneezing attacks
Phytolacca decandra 6C HPUS … Relieves mild fever
Pulsatilla 6C HPUS … Relieves colds with a loss of taste and smell

Uses*

temporarily relieves cold symptoms such as:

• sneezing
• runny nose
• nasal congestion

Stop use and ask doctor if sore throat, vomiting, skin rash, diarrhea, difficulty breathing, or fever above 100 ^o F (38 ^o C) develops, or if symptoms persist for more than 2 days or worsen, or new symptoms occur.

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

Directions

Children 6 months of age and older:

Give 1 dose at the onset of symptoms. Repeat up to 6 times a day. Decrease frequency with improvement.

Children under 6 months of age:

Ask a doctor.

1. Tear open the foil pouch at the notched edge.
2. Snap off one pre-measured dose.
3. Twist to open.
4. Squeeze entire contents into mouth.

do not use if glued carton flaps are open or if inner foil pouch and vials are not intact

do not refrigerate or freeze

after opening foil pouch: store unused vials in the foil pouch for no longer than 3 months

after opening the vial: the product must be used immediately
after administering discard vial

do not reuse

contains 0.0015% alcohol

Cold Relief*

Sneezing, Runny Nose, Nasal Congestion*

Calm symptoms Day or Night

Twist, Squeeze & Go

No Known Drug Interactions

40 Pre-measured liquid doses 0.34 fl oz (1 mL) per dose

30 Pre-measured liquid doses 0.34 fl oz (1 mL) per dose

5 Pre-measured liquid doses 0.34 fl oz (1 mL) per dose

*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.

alcohol, purified water

Questions or comments?

ColdCalm.com
BoironUSA.com
info@boiron.com
1-800-BOIRON-1 (1-800-264-7661)
Distributed by Boiron Inc.
Newtown Square, PA 19073

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

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9057 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ONION (ONION) ONION 3 [hp_C] APIS MELLIFERA (APIS MELLIFERA) APIS MELLIFERA 15 [hp_C] EUPATORIUM PERFOLIATUM FLOWERING TOP (EUPATORIUM PERFOLIATUM FLOWERING TOP) EUPATORIUM PERFOLIATUM FLOWERING TOP 3 [hp_C] GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_C] POTASSIUM DICHROMATE (DICHROMATE ION) POTASSIUM DICHROMATE 6 [hp_C] STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED 3 [hp_C] PHYTOLACCA AMERICANA ROOT (PHYTOLACCA AMERICANA ROOT) PHYTOLACCA AMERICANA ROOT 6 [hp_C] PULSATILLA VULGARIS (PULSATILLA VULGARIS) PULSATILLA VULGARIS 6 [hp_C]

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0220-9057-07 1 POUCH in 1 PACKAGE contains a POUCH 1 5 LIQUID in 1 POUCH This package is contained within the PACKAGE (0220-9057-07) 2 NDC:0220-9057-09 1 POUCH in 1 PACKAGE contains a POUCH 2 30 LIQUID in 1 POUCH This package is contained within the PACKAGE (0220-9057-09) 3 NDC:0220-9057-47 1 POUCH in 1 PACKAGE contains a POUCH 3 40 LIQUID in 1 POUCH This package is contained within the PACKAGE (0220-9057-47)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/01/2017

Labeler — Laboratoires Boiron (282560473)

Registrant — Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Operations
Boiron		282560473	manufacture (0220-9057)

Establishment
Name	Address	ID/FEI	Operations
Boiron		383674934	manufacture (0220-9057)

Revised: 09/2023 Laboratoires Boiron