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NDC 66492-0005-02 Headek Nasal 6; 3; 6; 6; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

Headek Nasal 6; 3; 6; 6; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

Headek Nasal is a NASAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics. The primary component is ARABICA COFFEE BEAN; ATROPA BELLADONNA; NITROGLYCERIN; SODIUM CARBONATE; SODIUM CHLORIDE.

Product Information

NDC	66492-0005
Product ID	66492-005_d44a0c64-2298-9c8f-e053-2a95a90a2bbf
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Headek Nasal
Proprietary Name Suffix	n/a
Non-Proprietary Name	Belladonna, Glonoinum, Coffea, Natrum Carb, Natrum Mur.
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	NASAL
Active Ingredient Strength	6; 3; 6; 6; 12
Active Ingredient Units	[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
Substance Name	ARABICA COFFEE BEAN; ATROPA BELLADONNA; NITROGLYCERIN; SODIUM CARBONATE; SODIUM CHLORIDE
Labeler Name	Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 66492-0005-02 (66492000502)

Pricing Information	N/A
NDC Package Code	66492-005-02
Billing NDC	66492000502
Package	30 mL in 1 BOTTLE, GLASS (66492-005-02)
Marketing Start Date	2011-02-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 976b9c85-68c9-46a5-9012-53cb24683b03 Details

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENTS (HPUS*): Belladonna 3X, 12X. Glonoinum 6X, 12X. Coffea 6X. Natrum Carb 6X. Natrum Mur 12X. (Relieves Headache & Migraine)

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

SPL UNCLASSIFIED SECTION

INDICATIONS: Temporarily relieves headaches and migraines.

SPL UNCLASSIFIED SECTION

WARNINGS: If symptoms persist or worsen, a health professional should be consulted. As with any drug, if you are pregnant or nursing seek the advice of your physician before using this product. Consult a physician for use in children under 12 years of age.

Keep this and all medicines out of the reach of children.

SPL UNCLASSIFIED SECTION

DOSAGE: Adults and children above 12 years: 1 spray in each nostril three to eight times daily. Consult a health care professional for use in children under 12 years of age.

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: There is a safety seal on the neck and cap of the bottle. Do not use this product if the safety seal is broken or missing.

SPL UNCLASSIFIED SECTION

INACTIVE INGREDIENTS: Demineralized Water, Sodium Chloride, Benzalkonium Chloride.

SPL UNCLASSIFIED SECTION

Manufactured for: Be Well Homeopathics Inc. Miami, FL 33178 • 1-877-438-3042

www.bewellhomeo.com

PRINCIPAL DISPLAY PANEL

NDC 66492-005-02

Be Well Homeopathics

HEADEK NASAL SPRAY

30ml

Headache/Migraines

INGREDIENTS AND APPEARANCE

HEADEK NASAL

belladonna, glonoinum, coffea, natrum carb, natrum mur. spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66492-005
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	3 [hp_X] in 30 mL
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	6 [hp_X] in 30 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	6 [hp_X] in 30 mL
SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D)	SODIUM CARBONATE	6 [hp_X] in 30 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	12 [hp_X] in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66492-005-02	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	02/22/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/22/2011

Labeler - Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics (052584997)

Revised: 12/2021

Document Id: d44a0c64-2298-9c8f-e053-2a95a90a2bbf

Set id: 976b9c85-68c9-46a5-9012-53cb24683b03

Version: 4

Effective Time: 20211229

Search by Drug Name or NDC

NDC 66492-0005-02 Headek Nasal 6; 3; 6; 6; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

Headek Nasal 6; 3; 6; 6; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

Product Information

Package

Package Images

NDC 66492-0005-02 (66492000502)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 976b9c85-68c9-46a5-9012-53cb24683b03 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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