COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF - drosera, arnica montana, bryonia, cetraria islandica, belladonna, coccus cacti, s

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ), ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW), BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B), CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1) (CETRARIA ISLANDICA SUBSP. ISLANDICA - UNII:BJ7YPN79A1), ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H), PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT), TIN (UNII: 387GMG9FH
Available from:
HOMEOLAB USA INC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Dry cough. Aches and pains, chest congestion. Painful cough. Cough with expectoration. Cold and fever. Cough with expectoration. Mucus, cough and chills. Restlessness, irritability and nocturnal awakenings. Restlessness and sleeplessness. This homeopathic medicine helps relieve symptoms associated with nighttime cough and cold: - dry cough - cough with expectoration - chest congestion - fever - aches and pains
Authorization status:
unapproved homeopathic
Authorization number:
60512-9021-4, 60512-9021-5, 60512-9021-9

COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF - drosera, arnica montana,

bryonia, cetraria islandica, belladonna, coccus cacti, stannum metallicum, chamomilla, coffea

cruda syrup

HOMEOLAB USA 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.

----------

DRUG FACTS

Drosera (Sundew) 1C

Arnica montana (Leopard`s bane) 3C

Bryonia (White bryony) 3C

Cetraria islandica (Iceland moss) 1C

Belladonna (Deadly nightshade) 3C

Coccus cacti (Cochineal) 3C

Stannum metallicum (Tin) 3C

Chamomilla (German chamomile) 4C

Coffea cruda (Coffee) 4C

The letters HPUS indicate that the components in this products are officially monographed in the

Homeopathic Pharmacopoeia of the United States.

PURPOSE

Dry cough.

Aches and pains, chest congestion.

Painful cough.

Cough with expectoration.

Cold and fever.

Cough with expectoration.

Mucus, cough and chills.

Restlessness, irritability and nocturnal awakenings.

Restlessness and sleeplessness.

USES

This homeopathic medicine helps relieve symptoms associated with nighttime cough and cold:

- dry cough

- cough with expectoration

- chest congestion

- fever

- aches and pains

WARNINGS

Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 5

days.

Keep out of reach of children.

DIRECTIONS

Do not use more than directed.

Do not take with food.

Take before bedtime. Repeat every 8 hours, as needed. Reduce intake with improvement or as directed

by a healthcare professional.

Age

Dos e

Children 6 years of age and older

1 teaspoon

Children 2 to 5 years of age

1/2 teaspoon

Children under 2 years of age

Ask a doctor

OTHER INFORMATION

Store at room temperature.

Do not use if seal is broken or missing.

INACTIVE INGREDIENTS

Purified water, sorbitol, caramel, sodium benzoate, potassium sorbate, citric acid.

CARTON

COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF

drosera, arnica montana, bryonia, cetraria islandica, belladonna, coccus cacti, stannum metallicum, chamomilla,

coffea cruda syrup

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 0 512-9 0 21

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DRO SERA RO TUNDIFO LIA (UNII: QR44N9 XPJQ) (DROSERA ROTUNDIFOLIA -

UNII:QR44N9 XPJQ)

DROSERA ROTUNDIFOLIA

1 [hp_C]

in 10 0 mL

ARNICA MO NTANA (UNII: O8 0 TY20 8 ZW) (ARNICA MONTANA - UNII:O8 0 TY20 8 ZW)

ARNICA MONTANA

3 [hp_C]

in 10 0 mL

BRYO NIA ALBA RO O T (UNII: T7J0 46 YI2B) (BRYONIA ALBA ROOT -

UNII:T7J0 46 YI2B)

BRYONIA ALBA ROOT

3 [hp_C]

in 10 0 mL

CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79 A1) (CETRARIA

ISLANDICA SUBSP. ISLANDICA - UNII:BJ7YPN79 A1)

CETRARIA ISLANDICA

SUBSP. ISLANDICA

1 [hp_C]

in 10 0 mL

ATRO PA BELLADO NNA (UNII: WQZ3G9 PF0 H) (ATROPA BELLADONNA -

UNII:WQZ3G9 PF0 H)

ATROPA BELLADONNA

3 [hp_C]

in 10 0 mL

PRO TO RTO NIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI -

UNII:LZB7TFX1LT)

PROTORTONIA CACTI

3 [hp_C]

in 10 0 mL

TIN (UNII: 38 7GMG9 FH5) (TIN - UNII:38 7GMG9 FH5)

3 [hp_C]

in 10 0 mL

MATRICARIA RECUTITA (UNII: G0 R4UBI2ZZ) (MATRICARIA RECUTITA -

UNII:G0 R4UBI2ZZ)

MATRICARIA RECUTITA

4 [hp_C]

in 10 0 mL

ARABICA CO FFEE BEAN (UNII: 3SW6 78 MX72) (ARABICA COFFEE BEAN -

UNII:3SW6 78 MX72)

ARABICA COFFEE BEAN

4 [hp_C]

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

CARAMEL (UNII: T9 D9 9 G2B1R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 0 512-9 0 21-9

250 mL in 1 BOTTLE

2

NDC:6 0 512-9 0 21-5

10 0 mL in 1 BOTTLE

3

NDC:6 0 512-9 0 21-4

30 mL in 1 BOTTLE

Marketing Information

HOMEOLAB USA INC

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 2/28 /20 11

Labeler -

HOMEOLAB USA INC (202032533)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

HOMEOLAB USA INC

20 20 32533

ma nufa c ture (6 0 512-9 0 21)

Revised: 8/2012

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