COMFORT FOR COLIC- comfort for kids liquid

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

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Active ingredient:
Chamomilla (Chamomile) 4X, Colocynthsis (Bitter cucumber) 4X, Pulsatilla (Wind flower) 4X, Aethusa cynapium (Fools parsley) 6x, Dioscorea villosa (wild yam) 6X, Magnesia Phosphorica (Magensium phophate) 6X
Available from:
Vitality Works, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
For the temporary relief of colic symptoms, including stomach pain, vomiting, gas, cramping and irritability. For the temporary relief of colic symptoms, including stomach pain, vomiting, gas, cramping and irritability
Authorization status:
unapproved homeopathic
Authorization number:
64616-116-01

COMFORT FOR COLIC- comfort for kids liquid

Vitality Works, 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.

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Comfort for Colic

Indications

For the temporary relief of colic symptoms, including stomach pain, vomiting, gas, cramping and

irritability.

For the temporary relief of colic symptoms, including stomach pain, vomiting, gas, cramping and

irritability

Directions

Do not use if printed neck seal is broken or missing, use only as directed. For infants up to 3 years of

age: give 4 dropsunder the tongue every 30 minutes for 4 doses. Then reduce to once every 4 hours as

needed or recommended by a doctor.

Active Ingredients

Chamomilla (Chamomile) 4X, Colocynthsis (Bitter cucumber) 4X, Pulsatilla (Wind flower) 4X, Aethusa

cynapium (Fools parsley) 6x, Dioscorea villosa (wild yam) 6X, Magnesia Phosphorica (Magensium

phophate) 6X

Inactive ingredients

USP Purified water, Vegetable glycerin

Warnings

Stop use and ask a doctor if

symptoms do not improve in 7 days or if new symptoms appear

if your child experiences recurring gastrointestinal upsets, frequent headaches or persistent fatigue

Keep out of reach of children. In case of accidental overdose, contact a medical professional or a

poison control center immediately.

Comments or Questions

Health for Kids Shelbourne Falls, MA 01370 USA

1-800-255-4463

www.herbsforkids.com

COMFORT FOR COLIC

comfort for kids liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 46 16 -116

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PULSATILLA PRATENSIS (UNII: 8 E272251DI) (PULSATILLA PRATENSIS -

UNII:8 E272251DI)

PULSATILLA PRATENSIS

4 [hp_X]

in 0 .0 5 mL

AETHUSA CYNAPIUM (UNII: M6 9 36 L9 53C) (AETHUSA CYNAPIUM -

UNII:M6 9 36 L9 53C)

AETHUSA CYNAPIUM

4 [hp_X]

in 0 .0 5 mL

DIO SCO REA VILLO SA TUBER (UNII: IWY3IWX2G8 ) (DIOSCOREA VILLOSA TUBER -

UNII:IWY3IWX2G8 )

DIOSCOREA VILLOSA

TUBER

6 [hp_X]

in 0 .0 5 mL

MAGNESIUM PHO SPHATE, DIBASIC (UNII: A1Y8 70 20 9 Z) (MAGNESIUM PHOSPHATE,

DIBASIC - UNII:A1Y8 70 20 9 Z)

MAGNESIUM PHOSPHATE,

DIBASIC

6 [hp_X]

in 0 .0 5 mL

CHAMO MILE (UNII: FGL36 8 5T2X) (CHAMOMILE - UNII:FGL36 8 5T2X)

CHAMOMILE

4 [hp_X]

in 0 .0 5 mL

CITRULLUS CO LO CYNTHIS FRUIT (UNII: 0 E49 E3V9 U6 ) (CITRULLUS

COLOCYNTHIS FRUIT - UNII:0 E49 E3V9 U6 )

CITRULLUS

COLOCYNTHIS FRUIT

4 [hp_X]

in 0 .0 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

Packag ing

Vitality Works, Inc.

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 46 16 -116 -

30 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

0 1/14/20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 7/0 5/20 13

Labeler -

Vitality Works, Inc. (137752817)

Registrant -

Vitality Works, Inc. (137752817)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Vitality Wo rks, Inc.

1377528 17

label(6 46 16 -116 ) , manufacture(6 46 16 -116 )

Revised: 12/2019

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