SINUS- oyster shell calcium carbonate, crude, goldenseal, potassium dichromate, and pulsatilla vulgaris tablet

Sinus by

Drug Labeling and Warnings

Sinus by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Formerly Hyland's #47, Hyland's Sinus is a traditional homeopathic formula for the relief of symptoms of runny nose with clear to yellow or milky discharge, and nasal and sinus congestion due to the common cold. Hyland's Sinus stimulates your body's natural healing response to relieve symptoms and is safe for adults and children.

Drug Facts

Active ingredients

Calcarea Carbonica 3X HPUS, Hydrastis Canadensis 6X HPUS, Kali Bichromicum 6X HPUS, Pulsatilla 6X HPUS

“HPUS” indicates that the active ingredients are in the

official Homeopathic Pharmacopoeia of the United States.

Uses

Temporarily relieves the symptoms of sinus pain and pressure, headache, and nasal congestion due to common cold or allergies.

Warnings

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Consult a physician if

• Symptoms persist for more than 7 days or worsen.
• Symptoms are accompanied by a high fever (over 101 °F).

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately.

Do not use if imprinted tamper-evident bottle band is broken or missing.

In case of emergency, contact a medical professional or a poison control center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

Adults and children 12 years and over

dissolve 2-3 tablets under tongue every 4 hours or as needed.

Children 6 to under 12 years

dissolve 1–2 tablets under tongue every 4 hours or as needed.

Questions or comments?

(800) 624-9659

Inactive ingredients

Acacia Gum, Lactose.

PURPOSE

Temporarily relieves the symptoms of sinus pain and pressure, headache, and nasal congestion due to common cold or allergies.

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

NDC: 54973-3188-1

Hyland's ®

HOMEOPATHIC

SINUS

Natural Relief for Sinus
Congestion Due to Colds

100
TABLETS

INGREDIENTS AND APPEARANCE

SINUS 
oyster shell calcium carbonate, crude, goldenseal, potassium dichromate, and pulsatilla vulgaris tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3188
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	3 [hp_X]
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X]
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	6 [hp_X]
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
LACTOSE (UNII: J2B2A4N98G)

Product Characteristics
Color	white (Off-white)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3188-1	1 in 1 CARTON	08/01/2014
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/01/2014

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3188) , pack(54973-3188)