SINUS CONGESTION HEADACHE (antimonium tartaricum, arsenicum iodatum, asafoetida, baptisia tinctoria, echinacea- angustifolia, eupatorium perfoliatum, euphorbia pilulifera, hepar sulphuris calcareum, hydrastis canadensis, kali bichromicum, kreosotum, lachesis mutus, magnesia carbonica, pyrogenium, silicea, teucrium marum spray

Sinus Congestion Headache by

Drug Labeling and Warnings

Sinus Congestion Headache by is a Homeopathic medication manufactured, distributed, or labeled by Liddell Laboratories, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

(in each spray) 5.88% of Antimonium Tartaricum 6X, Arsenicum Iodatum 200C, Asafoetida 30C, Baptisia Tinctoria 3X, Echinacea (Angustifolia) 3X, Eupatorium Perfoliatum 6X, Euphorbia Pilulifera 3X, Hepar Sulphuris Calcareum 30X, Hydrastis Canadensis 30C, Kali Bichromicum 30C, Kreosotum 30C, Lachesis Mutus 200C, Magnesia Carbonica 10X, 200C, Pyrogenium 200C, Silicea 30C, Teucrium Marum 3X.

USES:

May temporarily aid in sinus drainage and temporarily relieve these symptoms associated with sinus congestion and sinus related headache:

sinus congestion

sinus pressure

headache pain**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur.

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

If pregnant or breast feeding, ask a doctor before using this product.

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

Store at room temperature.

KEEP OUT OF REACH OF CHILDREN:

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

DIRECTIONS:

Adults and children over 12: Spray twice under the tongue three times per day. For severe symptoms, dosage may be taken up to six times the first day.

Children 12 and under: Consult a doctor prior to use.

USES:

May temporarily aid in sinus drainage and temporarily relieve these symptoms associated with sinus congestion and sinus related headache:

sinus congestion

sinus pressure

headache pain**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

Organic alcohol 20% v/v, Purified water.

QUESTIONS:

DIST. BY

LIDDELL LABORATORIES, INC.

201 APPLE BLVD.

WOODBINE, IA 51579

WWW.LIDDELL.NET

1-800-460-7733

PACKAGE LABEL DISPLAY:

ORAL SPRAYS
LIDDELL
LABORATORIES

EST. 1994

09 ScH
Sinus
Congestion
+ Headache

May aid in sinus drainage +
relieve these symptoms: sinus
congestion, sinus pressure +
headache pain.

HOMEOPATHIC

DOCTOR FORMULATED

Readily absorbed. Safe.
No known side effects. Easy to use.

1.0 FL OZ. (30 ml)

INGREDIENTS AND APPEARANCE

SINUS CONGESTION HEADACHE 
antimonium tartaricum, arsenicum iodatum, asafoetida, baptisia tinctoria, echinacea (angustifolia), eupatorium perfoliatum, euphorbia pilulifera, hepar sulphuris calcareum, hydrastis canadensis, kali bichromicum, kreosotum, lachesis mutus, magnesia carbonica, pyrogenium, silicea, teucrium marum spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50845-0243
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5)	ANTIMONY POTASSIUM TARTRATE	6 [hp_X]  in 1 mL
ARSENIC TRIIODIDE (UNII: 3029988O2T) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIIODIDE	200 [hp_C]  in 1 mL
ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1)	ASAFETIDA	30 [hp_C]  in 1 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	3 [hp_X]  in 1 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	3 [hp_X]  in 1 mL
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	6 [hp_X]  in 1 mL
EUPHORBIA HIRTA FLOWERING TOP (UNII: 6H89ZY31MR) (EUPHORBIA HIRTA FLOWERING TOP - UNII:6H89ZY31MR)	EUPHORBIA HIRTA FLOWERING TOP	3 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	30 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	30 [hp_C]  in 1 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	30 [hp_C]  in 1 mL
WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73)	WOOD CREOSOTE	30 [hp_C]  in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	200 [hp_X]  in 1 mL
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	10 [hp_X]  in 1 mL
RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU)	RANCID BEEF	200 [hp_C]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	30 [hp_C]  in 1 mL
TEUCRIUM MARUM (UNII: 10464S0TAA) (TEUCRIUM MARUM - UNII:10464S0TAA)	TEUCRIUM MARUM	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: 50845-0243-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/16/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/16/2018

Labeler - Liddell Laboratories, Inc. (832264241)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(50845-0243) , api manufacture(50845-0243) , label(50845-0243) , pack(50845-0243)