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NDC 71409-0311-80 Sore Throat Relief 10; 10; 10; 10; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

Sore Throat Relief 10; 10; 10; 10; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

Sore Throat Relief is a ORAL; SUBLINGUAL PELLET in the HUMAN OTC DRUG category. It is labeled and distributed by Clineva Urgent Care. The primary component is ACONITUM NAPELLUS; APIS MELLIFERA; ATROPA BELLADONNA; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; SOLANUM DULCAMARA WHOLE.

Product Information

NDC	71409-0311
Product ID	71409-311_620e0d1d-b067-2a86-e053-2a91aa0a9bef
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	Sore Throat Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sore Throat Relief
Product Type	HUMAN OTC DRUG
Dosage Form	PELLET
Route	ORAL; SUBLINGUAL
Active Ingredient Strength	10; 10; 10; 10; 8; 8
Active Ingredient Units	[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Substance Name	ACONITUM NAPELLUS; APIS MELLIFERA; ATROPA BELLADONNA; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; SOLANUM DULCAMARA WHOLE
Labeler Name	Clineva Urgent Care
Pharmaceutical Class	Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71409-0311-80 (71409031180)

Pricing Information	N/A
NDC Package Code	71409-311-80
Billing NDC	71409031180
Package	80 PELLET in 1 VIAL, DISPENSING (71409-311-80)
Marketing Start Date	2017-07-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 549d9cc4-13df-57ad-e054-00144ff8d46c Details

Directions

Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.

Active ingredients:

(HPUS) Homeopathic Medicine

Aconitum nap. 10X, Apis mellifica 10X, Belladonna 10X, Dulcamara 8X, Mercurius sol. 10X, Phytolacca decandra 8X

Uses:

For the temporary relief of minor sore throat or irritation associated with the common cold or the flu.

Warnings:

Severe or persistent sore throst or sore throat accompanied by high fever, headache, nausea, and vomitting may be serious. Consult a doctor promptly. If pregnant or nursing, ask a physician before use. Do not use if cap seal is broken or missing.

Keep out of reach of children.

Inactive ingredients:

Sucrose/lactose

Questions, Comments?

Call 1-844-254-6382

Dist. by Clineva Urgent Care

29100 Portola Pkwy

Lake Forest, CA 92630

SPL UNCLASSIFIED SECTION

Uses: For the temporary relief of minor sore throat or irritation associated with the common cold or the flu.

SORE THROAT RELIEF

INGREDIENTS AND APPEARANCE

SORE THROAT RELIEF

sore throat relief pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71409-311
Route of Administration	ORAL, SUBLINGUAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	10 [hp_X]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	10 [hp_X]
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	10 [hp_X]
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	8 [hp_X]
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	10 [hp_X]
SOLANUM DULCAMARA WHOLE (UNII: G72JA9DHK5) (SOLANUM DULCAMARA WHOLE - UNII:G72JA9DHK5)	SOLANUM DULCAMARA WHOLE	8 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
LACTOSE (UNII: J2B2A4N98G)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white	Score
Shape	ROUND	Size	4mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71409-311-80	80 in 1 VIAL, DISPENSING; Type 0: Not a Combination Product	07/18/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/18/2017

Labeler - Clineva Urgent Care (092689945)

Registrant - HomeoCare Laboratories (088248828)

Name	Address	ID/FEI	Business Operations
Establishment
HomeoCare Laboratories Inc.		088248828	manufacture(71409-311)

Revised: 1/2018

Document Id: 620e0d1d-b067-2a86-e053-2a91aa0a9bef

Set id: 549d9cc4-13df-57ad-e054-00144ff8d46c

Version: 2

Effective Time: 20180105