365 EVERYDAY VALUE BE WELL COUGH EASE FOR KIDS- antimony potassium tartrate, bryonia alba root, protortonia cacti, drosera rotundifolia, ipecac, pulsatilla vulgaris, rumex crispus root, pongia officinalis skeleton, roasted, lobaria pulmonaria syrup

365 Everyday Value Be Well Cough Ease for Kids by

Drug Labeling and Warnings

365 Everyday Value Be Well Cough Ease for Kids by is a Homeopathic medication manufactured, distributed, or labeled by WFM Private Label, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Antimonium tartaricum 6C
Bryonia alba 3C
Coccus cacti 3C
Drosera rotundifolia 3C
Ipecacuanha 3C
Pulsatilla 6C
Rumex crispus 6C
Spongia tosta 3C
Sticta pulmonaria 3C

INDICATIONS & USAGE

Temporary relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Helps loosen phlegms (mucus) and thin bronchial secretions to make coughs more productive.

DO NOT USE

Do not use if seal at base of cap is broken or missing.

DOSAGE & ADMINISTRATION

Children 2 to 12 years 1 teaspoon every 2 hours

Younger than 2 years of age not recommended

INACTIVE INGREDIENT

citric acid, honey, purified water, sodium benzoate, sucrose

HOW SUPPLIED

200 Ml

PURPOSE

Antimonium tartaricum 6C  Helps loosen thick mucus
Bryonia alba 3C  Relieves dry and painful cough
Coccus cacti 3C  Relieves cough associated with a tickling in the throat
Drosera rotundifolia 3C  Relieves barking cough worse at night
Ipecacuanha 3C Relieves cough associated with nausea
Pulsatilla 6C  Relieves wet cough during the day becoming worse at night
Rumex crispus 6C Relieves dry cough triggered by cold air
Spongia tosta 3C Relieves dry, croupy and barking cough
Sticta pulmonaria 3C Relieves nighttime hacking cough

STORAGE AND HANDLING

Do not store above 77 O F (25 O C)

QUESTIONS

Questions, Comments?

customer.question@wholefoods.com

ASK DOCTOR

Ask a doctor before use if he child has

Cough that occurs with too much phlegm (mucus)

Cough that last or is chronic such as occurs with asthma or chronic bronchitis.

STOP USE

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache. These could be a sign of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING

WHEN USING

DRUG INTERACTIONS

WARNINGS

Principle Display Panel

Package images

INGREDIENTS AND APPEARANCE

365 EVERYDAY VALUE BE WELL COUGH EASE FOR KIDS 
antimony potassium tartrate, bryonia alba root, protortonia cacti, drosera rotundifolia, ipecac, pulsatilla vulgaris, rumex crispus root, pongia officinalis skeleton, roasted, lobaria pulmonaria syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42681-9033
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	3 [hp_C]  in 1 mL
PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT)	PROTORTONIA CACTI	3 [hp_C]  in 1 mL
DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ)	DROSERA ROTUNDIFOLIA	3 [hp_C]  in 1 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	3 [hp_C]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_C]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C)	RUMEX CRISPUS ROOT	6 [hp_C]  in 1 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID)	SPONGIA OFFICINALIS SKELETON, ROASTED	3 [hp_C]  in 1 mL
LOBARIA PULMONARIA (UNII: D1YM0P5Z2T) (LOBARIA PULMONARIA - UNII:D1YM0P5Z2T)	LOBARIA PULMONARIA	3 [hp_C]  in 1 mL
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5)	ANTIMONY POTASSIUM TARTRATE	6 [hp_C]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HONEY (UNII: Y9H1V576FH)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color		Score
Shape		Size
Flavor	HONEY (Honey)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42681-9033-1	125 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2011	08/30/2018
2	NDC: 42681-9033-2	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/03/2011

Labeler - WFM Private Label, LP (196175616)

Registrant - Boiron, Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(42681-9033)