Search by Drug Name or NDC

NDC 71409-0304-80 COLD and FLU RELIEF 14; 8; 8; 8; 18; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

COLD and FLU RELIEF 14; 8; 8; 8; 18; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

COLD and FLU RELIEF is a ORAL; SUBLINGUAL PELLET in the HUMAN OTC DRUG category. It is labeled and distributed by Clineva Management Services, LLC. The primary component is ACONITUM NAPELLUS; ALLIUM CEPA WHOLE; ARNICA MONTANA; EUPATORIUM CANNABINUM WHOLE; GELSEMIUM SEMPERVIRENS ROOT; SOLANUM DULCAMARA WHOLE.

Product Information

NDC	71409-0304
Product ID	71409-304_7057d504-679a-5dfe-e053-2991aa0a8093
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	COLD and FLU RELIEF
Proprietary Name Suffix	n/a
Non-Proprietary Name	COLD and FLU RELIEF
Product Type	HUMAN OTC DRUG
Dosage Form	PELLET
Route	ORAL; SUBLINGUAL
Active Ingredient Strength	14; 8; 8; 8; 18; 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; ALLIUM CEPA WHOLE; ARNICA MONTANA; EUPATORIUM CANNABINUM WHOLE; GELSEMIUM SEMPERVIRENS ROOT; SOLANUM DULCAMARA WHOLE
Labeler Name	Clineva Management Services, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71409-0304-80 (71409030480)

Pricing Information	N/A
NDC Package Code	71409-304-80
Billing NDC	71409030480
Package	80 PELLET in 1 VIAL, DISPENSING (71409-304-80)
Marketing Start Date	2017-07-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 544c918d-86cc-1f8d-e054-00144ff8d46c Details

Inactive Ingredients

Sucrose

Lactose

Active ingredients

Acon. nap 14X, Allium cepa 8X, Arnica m. 8X, Dulcamara 8X, Eupatorium cann. 8X, Gelsemium 18X

Directions:

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

Warnings:

Keep out of reach of children.

Uses:

*For the temporary relief of minor fever, chills, runny nose, congestion, body aches adn fatigue due to the common cold or the flu.

Warnings

If symptoms persist or worsen, or if pregnant or nursing, consult a doctor. Keep out of reach of children. Do not use if cap seal is broken or missing.

Question, Comments?

Call 1-844-254-6382

SPL UNCLASSIFIED SECTION

Uses: For the temporary relief of minor fever, chills, runny nose, congestion, body aches and fatigue due to the common cold or the flu

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLD AND FLU RELIEF

cold and flu relief pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71409-304
Route of Administration	ORAL, SUBLINGUAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALLIUM CEPA WHOLE (UNII: 8P2VLG2456) (ALLIUM CEPA WHOLE - UNII:8P2VLG2456)	ALLIUM CEPA WHOLE	8 [hp_X]
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	14 [hp_X]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	8 [hp_X]
SOLANUM DULCAMARA WHOLE (UNII: G72JA9DHK5) (SOLANUM DULCAMARA WHOLE - UNII:G72JA9DHK5)	SOLANUM DULCAMARA WHOLE	8 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	18 [hp_X]
EUPATORIUM CANNABINUM WHOLE (UNII: 1UEC056CS0) (EUPATORIUM CANNABINUM WHOLE - UNII:1UEC056CS0)	EUPATORIUM CANNABINUM WHOLE	8 [hp_X]

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

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:71409-304-80	80 in 1 VIAL, DISPENSING; Type 0: Not a Combination Product	07/14/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/14/2017

Labeler - Clineva Management Services, LLC (092689945)

Registrant - HomeoCare Laboratories Inc. (088248828)

Name	Address	ID/FEI	Business Operations
Establishment
HomeoCare Laboratories		088248828	manufacture(71409-304)

Revised: 7/2018

Document Id: 7057d504-679a-5dfe-e053-2991aa0a8093

Set id: 544c918d-86cc-1f8d-e054-00144ff8d46c

Version: 3

Effective Time: 20180706