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

INFANT COLD by

Drug Labeling and Warnings

INFANT COLD by is a Homeopathic medication manufactured, distributed, or labeled by CVS PHARMACY, HOMEOLAB USA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Purpose

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

Uses

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-377
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	6 [hp_X]  in 125
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	6 [hp_X]  in 125
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_X]  in 125
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	6 [hp_X]  in 125

Inactive Ingredients
Ingredient Name	Strength
DEXTROSE (UNII: IY9XDZ35W2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 68401960MK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-377-03	1 in 1 CARTON
1		125 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/07/2014

Labeler - CVS PHARMACY (062312574)

Registrant - HOMEOLAB USA INC (202032533)

Establishment
Name	Address	ID/FEI	Business Operations
HOMEOLAB USA INC		202032533	manufacture(59779-377)