HEADACHE- cimicifuga racemosa, gelsemium sempervirens, rhus tox, liquid

Headache by

Drug Labeling and Warnings

Headache by is a Homeopathic medication manufactured, distributed, or labeled by Deseret Biologicals, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Cimicifuga Racemosa 2X, 10X, 30X, 200X, Gelsemium Sempervirens 3X, 10X, 30X, 200X, Rhus Tox 3X, 10X, 30X, 200X.

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to headache including exhaustion, fever, chills, head and muscle pain.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

Keep out of reach of children.  In case of overdose, Contact physician or Poison Control Center right away.

If pregnant or breast-feeding, seek advice of a health professional before use.

Tamper seal:  "Sealed for Your Protection."  Do not use if seal is broken or missing.

DIRECTIONS:

1-10 drops under the tongue, 3 times a day or as directed by a health professional.  Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

 Demineralized Water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to headache including exhaustion, fever, chills, head and muscle pain.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

QUESTIONS:

Dist. By:  Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070       www.desbio.com

PACKAGE LABEL DISPLAY:

DESBIO

NDC: 43742-0067-1

HOMEOPATHIC

HEADACHE

1 FL OZ (30 ml)

INGREDIENTS AND APPEARANCE

HEADACHE 
cimicifuga racemosa, gelsemium sempervirens, rhus tox, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43742-0067
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	2 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	3 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	3 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43742-0067-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/07/2015	08/12/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/10/2012	08/12/2021

Labeler - Deseret Biologicals, Inc. (940741853)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43742-0067) , api manufacture(43742-0067) , label(43742-0067) , pack(43742-0067)