NativeRemedies® DigestoCalm™ Oral Spray

DigestoCalm by

Drug Labeling and Warnings

DigestoCalm by is a Homeopathic medication manufactured, distributed, or labeled by Silver Star Brands, King Bio. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DIGESTOCALM- argentum nitricum, calcarea phosphorica, colcynthis, ferrum phosphoricum, nux vomica spray 
Silver Star Brands

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.

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NativeRemedies® DigestoCalm™ Oral Spray

HPUS Active Ingredients:

Equal volumes of each ingredient: Argentum nitricum 30C, Calcarea phosphorica 6C, Colocynthis 30C, Ferrum phosphoricum 30C, Nux vomica 6C.

Uses*:

For temporary relief of symptoms of digestive discomfort and for support of digestive health.

*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Warnings:

If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily. Use additionally as needed or until symptoms improve. Adults: Take 3 pump sprays. Children under 12: Take 2 pump sprays.

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www. nativeremedies.com.

Contains no artificial flavors or colorants. No gluten added.

Inactive Ingredients:

Citric acid, potassium sorbate, purified water.

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

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

Temporarily relieves symptoms of digestive discomfort

DIGESTOCALM 
argentum nitricum, calcarea phosphorica, colcynthis, ferrum phosphoricum, nux vomica spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-264
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STRYCHNOS NUX-VOMICA WHOLE (UNII: AB2NX17POS) (STRYCHNOS NUX-VOMICA WHOLE - UNII:AB2NX17POS)	STRYCHNOS NUX-VOMICA WHOLE	6 [hp_C]  in 59 mL
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM PHOSPHATE	6 [hp_C]  in 59 mL
CITRULLUS COLOCYNTHIS WHOLE (UNII: Z70W98921V) (CITRULLUS COLOCYNTHIS WHOLE - UNII:Z70W98921V)	CITRULLUS COLOCYNTHIS WHOLE	30 [hp_C]  in 59 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	30 [hp_C]  in 59 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	30 [hp_C]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-264-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/24/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/24/2016	02/11/2020

Labeler - Silver Star Brands (006070379)

Registrant - Silver Star Brands (006070379)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio		617901350	manufacture(68703-264) , api manufacture(68703-264)

Revised: 2/2020

Document Id: 9e5244fc-ef57-3ac3-e053-2a95a90ae105

34390-5

Set id: 3f2a4d6b-e3cf-22a4-e054-00144ff88e88

Version: 2

Effective Time: 20200211