Search by Drug Name or NDC

NDC 71971-9999-09 Kids Relief 4; 3; 3; 1; 4; 3; 1; 3; 3; 3 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL Details

Kids Relief 4; 3; 3; 1; 4; 3; 1; 3; 3; 3 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL

Kids Relief is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Homeolab International (Canada) inc. The primary component is ARABICA COFFEE BEAN; ARNICA MONTANA; BRYONIA ALBA WHOLE; CETRARIA ISLANDICA SUBSP. ISLANDICA; CHAMOMILE; CORALLIUM RUBRUM WHOLE; DROSERA ROTUNDIFOLIA FLOWERING TOP; IPECAC; PROTORTONIA CACTI; TIN.

Product Information

NDC	71971-9999
Product ID	71971-9999_ee1654f2-9006-4794-af29-87f56472648d
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	Kids Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	DROSERA, ARNICA MONTANA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM, CAMOMILLA, COFFEA CRUDEA
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	4; 3; 3; 1; 4; 3; 1; 3; 3; 3
Active Ingredient Units	[hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL
Substance Name	ARABICA COFFEE BEAN; ARNICA MONTANA; BRYONIA ALBA WHOLE; CETRARIA ISLANDICA SUBSP. ISLANDICA; CHAMOMILE; CORALLIUM RUBRUM WHOLE; DROSERA ROTUNDIFOLIA FLOWERING TOP; IPECAC; PROTORTONIA CACTI; TIN
Labeler Name	Homeolab International (Canada) inc
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71971-9999-09 (71971999909)

Pricing Information	N/A
NDC Package Code	71971-9999-9
Billing NDC	71971999909
Package	250 mL in 1 BOTTLE (71971-9999-9)
Marketing Start Date	2018-05-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL da5677ec-63fd-4467-9755-479d0ab51df5 Details

SPL UNCLASSIFIED SECTION

Active Ingredients HPUS:

Drosera 1C

Arnica montana 3C

Bryonia 3C

Ipecacuanha 3C

Cetraria islandica 1C

Coccus cacti 3C

Corallium rubrum 3C

Stannum metallicum 3C

Camomilla 4C

Coffea crudea 4C

SPL UNCLASSIFIED SECTION

Purpose

Drosera 1C......................................dry cough

Arnica montana 3C...........................aches and pains, chest congestion

Bryonia 3C......................................painful cough

Ipecacuanha 3C...............................night cough

Cetraria islandica 1C.........................cough with expectoration

Coccus cacti 3C................................cough with expectoration

Corallium rubrum 3C.........................painful cough

Stannum metallicum 3C.....................cough, chills, and lessens mucus

Camomilla 4C...................................restlessness, irritability, nocturnal awakenings

Coffea crudea 4C..............................restlessness and sleeplessness

The letters "HPUS" indicate that the components in this product are officially

monographed in the Homeopathic Pharcopoeia of the United States

SPL UNCLASSIFIED SECTION

Uses This homeopathic medicine is made from a combination

of ingredients traditionally used to help relieve

symptoms associated with nighttime cough and cold*:

•dry cough •cough with expectoration

•chest congestion •fever •aches and pains

SPL UNCLASSIFIED SECTION

Warnings

Stop use and ask a doctor if •pain or cough gets worse

or lasts more than 5 days (children) or 7 days (adults)

•fever gets worse or lasts more than 3 days •redness

or swelling is present •new symptoms occur •cough

comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition

SPL UNCLASSIFIED SECTION

Keep out of reach of children. In case of accidental

overdose, contact a medical professional or a poison

control center immediately.

SPL UNCLASSIFIED SECTION

Directions •Children under 6 months of age: Consult a

licensed healthcare practitioner before using this product

•Children 6 months to 2 years old: 2.5 ml or 1.2 teaspoon,

every 8 hours or 3 times a day •Children 2 to 12 years

old: 5 ml or 1 teaspoon, every 8 hours or 3 times a day

SPL UNCLASSIFIED SECTION

Other information •Store at room temperature.

•do not use if seal is broken or missing

SPL UNCLASSIFIED SECTION

Inactive ingredients Purified water, sorbitol,

caramel, sodium benzoate, potassium sorbate, citric acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KIDS RELIEF

drosera, arnica montana, bryonia, ipecacuanha, cetraria islandica, coccus cacti, corallium rubrum, stannum metallicum, camomilla, coffea crudea liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71971-9999
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG)	DROSERA ROTUNDIFOLIA FLOWERING TOP	1 [hp_C] in 100 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_C] in 100 mL
BRYONIA ALBA WHOLE (UNII: 56K0VVT47P) (BRYONIA ALBA WHOLE - UNII:56K0VVT47P)	BRYONIA ALBA WHOLE	3 [hp_C] in 100 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	3 [hp_C] in 100 mL
CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1) (CETRARIA ISLANDICA SUBSP. ISLANDICA - UNII:BJ7YPN79A1)	CETRARIA ISLANDICA SUBSP. ISLANDICA	1 [hp_C] in 100 mL
PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT)	PROTORTONIA CACTI	3 [hp_C] in 100 mL
CORALLIUM RUBRUM WHOLE (UNII: 22Z32PWR7R) (CORALLIUM RUBRUM WHOLE - UNII:22Z32PWR7R)	CORALLIUM RUBRUM WHOLE	3 [hp_C] in 100 mL
TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5)	TIN	3 [hp_C] in 100 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	4 [hp_C] in 100 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	4 [hp_C] in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
CARAMEL (UNII: T9D99G2B1R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color		Score
Shape		Size
Flavor	grape	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71971-9999-5	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2018
2	NDC:71971-9999-9	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/03/2018

Labeler - Homeolab International (Canada) inc (203639455)

Revised: 12/2019

Document Id: ee1654f2-9006-4794-af29-87f56472648d

Set id: da5677ec-63fd-4467-9755-479d0ab51df5

Version: 2

Effective Time: 20191210

Search by Drug Name or NDC

NDC 71971-9999-09 Kids Relief 4; 3; 3; 1; 4; 3; 1; 3; 3; 3 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL Details

Kids Relief 4; 3; 3; 1; 4; 3; 1; 3; 3; 3 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL

Product Information

Package

Package Images

NDC 71971-9999-09 (71971999909)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL da5677ec-63fd-4467-9755-479d0ab51df5 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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