INFANT COLD- euphrasia officinalis, eupatorium perfoliatum, gelsemium sempervirens, kali iodatum tablet, orally disintegrating

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

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Active ingredient:
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL), EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E), GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q), POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)
Available from:
CVS PHARMACY
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Euphrasia officinalis 6X..................................Runny eyes and nose Eupatorium perfoliatum 6X.............................Sneezing, cough, headache Gelsemium sempervirens 6X...........................Stuffy nose, sneezing Kali iodatum 6X.............................................Runny eyes and nose, headache Temporarily relieves the symptoms of runny nose, congestion and sneezing due to common head colds in children.* *These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.
Authorization status:
unapproved homeopathic
Authorization number:
59779-377-03

INFANT COLD- euphrasia officinalis, eupatorium perfoliatum, gelsemium sempervirens, kali

iodatum tablet, orally disintegrating

CVS PHARMACY

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

Active ingredients HPUS

Euphrasia officinalis 6X

Eupatorium perfoliatum 6X

Gelsemium sempervirens 6X

Kali iodatum 6X

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

Homoeopathic Pharmacopoeia of the United States.

Purpos e

Euphrasia officinalis 6X..................................Runny eyes and nose

Eupatorium perfoliatum 6X.............................Sneezing, cough, headache

Gelsemium sempervirens 6X...........................Stuffy nose, sneezing

Kali iodatum 6X.............................................Runny eyes and nose, headache

Us es

Temporarily relieves the symptoms of runny nose, congestion and sneezing due to common head colds

in children.*

*These claims have not been reviewed by the Food and Drug Administration. They are based on

traditional homeopathic practice.

Warnings

As with any drug, ask a doctor before use if pregnant or nursing.

Stop use and ask a doctor if:

symptoms persist for more than 72 hours or worsen

if symptoms are accompanied by a high fever (over 101°F).

Keep this and all medications out of the reach of children.

In case of emergency or accidental

overdose, contact a medical professional or a poison control center immediately.

Do not use if security seal is broken or missing.

Directions

Children under 6 months of

age:

Consult a licensed health care professional before using this

product.

Children 6 months to 1 year of age:

Dissolve 2 tablets on the tongue every 15 minutes for 4 doses,

then hourly until relieved, or as directed by a licensed health care professional.

Children 1 to 3 years of age:

Dissolve 3 tablets on the tongue every 15 minutes for 4 doses, then

hourly until relieved, or as directed by a licensed health care professional.

CVS/pharmacy Infant Cold Tablets are very soft and will dissolve almost instantly in the mouth.

Other information

Store at room temperature (68-77°F)

Inactive ingredients

Dextrose, maltodextrin, corn starch, crospovidone, magnesium stearate, lactose.

INFANT COLD

euphrasia officinalis, eupatorium perfoliatum, gelsemium sempervirens, kali iodatum tablet, orally disintegrating

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 779 -377

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

EUPHRASIA STRICTA (UNII: C9 6 42I9 1WL) (EUPHRASIA STRICTA - UNII:C9 6 42I9 1WL)

EUPHRASIA STRICTA

6 [hp_X]

in 125

EUPATO RIUM PERFO LIATUM FLO WERING TO P (UNII: 1W0 775VX6 E)

(EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0 775VX6 E)

EUPATORIUM PERFOLIATUM

FLOWERING TOP

6 [hp_X]

in 125

GELSEMIUM SEMPERVIRENS RO O T (UNII: 6 39 KR6 0 Q1Q) (GELSEMIUM

SEMPERVIRENS ROOT - UNII:6 39 KR6 0 Q1Q)

GELSEMIUM SEMPERVIRENS

ROOT

6 [hp_X]

in 125

PO TASSIUM IO DIDE (UNII: 1C4QK22F9 J) (IODIDE ION - UNII:0 9 G4I6 V8 6 Q)

IODIDE ION

6 [hp_X]

in 125

Inactive Ingredients

Ingredient Name

Stre ng th

DEXTRO SE (UNII: IY9 XDZ35W2)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

STARCH, CO RN (UNII: O8 232NY3SJ)

CRO SPO VIDO NE (UNII: 6 8 40 19 6 0 MK)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

Product Characteristics

Color

white

S core

no sco re

S hap e

ROUND

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 779 -377-0 3

1 in 1 CARTON

1

125 in 1 BOTTLE, PLASTIC

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 2/0 7/20 14

Labeler -

CVS PHARMACY (062312574)

Registrant -

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 (59 779 -377)

CVS PHARMACY

HOMEOLAB USA INC

20 20 32533

ma nufa c ture (59 779 -377)

Revised: 2/2014

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