Sinus Congestion Headache: Homeopathic Product Information

SINUS CONGESTION HEADACHE- antimony potassium tartrate, asafetida, baptisia tinctoria root, echinacea angustifolia, eupatorium perfoliatum flowering top, euphorbia hirta flowering top, calcium sulfide, goldenseal, iodine, potassium dichromate, lachesis muta venom, magnesium carbonate, sus scrofa nasal mucosa, anemone pulsatilla, rancid beef, silicon dioxide and teucrium marum spray
Liddell Laboratories, Inc.

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.

ACTIVE INGREDIENTS:

(in each spray) 5.56% of Antimonium Tartaricum 6X,Asafoetida 30C, Baptisia Tinctoria 3X, Echinacea (Angustifolia) 3X, Eupatorium Perfoliatum 6X, Euphorbia Pilulifera 3X, Hepar Sulphuris Calcareum 30X, Hydrastis Canadensis 30C, Iodium 200C, Kali Bichromicum 30C, Lachesis Mutus 200C, Magnesia Carbonica 10X, 200C, Mucosa Nasalis Suis 12X, Pulsatilla (Vulgaris) 30C, 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 for more than 7 days, 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.

INDICATIONS:

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)

Sinus Congestion + Headache lbl
(click image for full-size original)
Sinus Congestion + Headache ctn
(click image for full-size original)
SINUS CONGESTION HEADACHE
antimonium tartaricum, asafoetida, baptisia tinctoria, echinacea (angustifolia), eupatorium perfoliatum, euphorbia pilulifera, hepar sulphuris calcareum, hydrastis canadensis, iodium, kali bichromicum, lachesis mutus, magnesia carbonica, mucosa nasalis suis, pulsatilla (vulgaris), pyrogenium, silicea, teucrium marum spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50845-0254
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANTIMONY POTASSIUM TARTRATE (ANTIMONY CATION (3+)) ANTIMONY POTASSIUM TARTRATE 6 [hp_X] in 1 mL
ASAFETIDA (ASAFETIDA) ASAFETIDA 30 [hp_C] in 1 mL
BAPTISIA TINCTORIA ROOT (BAPTISIA TINCTORIA ROOT) BAPTISIA TINCTORIA ROOT 3 [hp_X] in 1 mL
ECHINACEA ANGUSTIFOLIA (ECHINACEA ANGUSTIFOLIA) ECHINACEA ANGUSTIFOLIA 3 [hp_X] in 1 mL
EUPATORIUM PERFOLIATUM FLOWERING TOP (EUPATORIUM PERFOLIATUM FLOWERING TOP) EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X] in 1 mL
EUPHORBIA HIRTA FLOWERING TOP (EUPHORBIA HIRTA FLOWERING TOP) EUPHORBIA HIRTA FLOWERING TOP 3 [hp_X] in 1 mL
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 30 [hp_X] in 1 mL
GOLDENSEAL (GOLDENSEAL) GOLDENSEAL 30 [hp_C] in 1 mL
IODINE (IODINE) IODINE 200 [hp_C] in 1 mL
POTASSIUM DICHROMATE (DICHROMATE ION) POTASSIUM DICHROMATE 30 [hp_C] in 1 mL
LACHESIS MUTA VENOM (LACHESIS MUTA VENOM) LACHESIS MUTA VENOM 200 [hp_C] in 1 mL
MAGNESIUM CARBONATE (CARBONATE ION) MAGNESIUM CARBONATE 10 [hp_X] in 1 mL
SUS SCROFA NASAL MUCOSA (SUS SCROFA NASAL MUCOSA) SUS SCROFA NASAL MUCOSA 12 [hp_X] in 1 mL
ANEMONE PULSATILLA (ANEMONE PULSATILLA) ANEMONE PULSATILLA 30 [hp_C] in 1 mL
RANCID BEEF (RANCID BEEF) RANCID BEEF 200 [hp_C] in 1 mL
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 30 [hp_C] in 1 mL
TEUCRIUM MARUM (TEUCRIUM MARUM) TEUCRIUM MARUM 3 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50845-0254-2 1 BOTTLE, SPRAY in 1 PACKAGE contains a BOTTLE, SPRAY (50845-0254-1)
1 NDC:50845-0254-1 30 mL in 1 BOTTLE, SPRAY This package is contained within the PACKAGE (50845-0254-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 04/24/2019 06/30/2024
Labeler — Liddell Laboratories, Inc. (832264241)
Registrant — Apotheca Company (844330915)
Establishment
Name Address ID/FEI Operations
Apotheca Company 844330915 manufacture (50845-0254), api manufacture (50845-0254), label (50845-0254), pack (50845-0254)

Revised: 12/2021 Liddell Laboratories, Inc.

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