INFANT COLD: Homeopathic Product Information

INFANT COLD- euphrasia stricta, eupatorium perfoliatum flowering top, gelsemium sempervirens root and potassium iodide 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.

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.

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUPHRASIA STRICTA (EUPHRASIA STRICTA) EUPHRASIA STRICTA 6 [hp_X] in 125
EUPATORIUM PERFOLIATUM FLOWERING TOP (EUPATORIUM PERFOLIATUM FLOWERING TOP) EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X] in 125
GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] in 125
POTASSIUM IODIDE (IODIDE ION) IODIDE ION 6 [hp_X] in 125
Inactive Ingredients
Ingredient Name Strength
DEXTROSE
MALTODEXTRIN
STARCH, CORN
CROSPOVIDONE
MAGNESIUM STEARATE
LACTOSE MONOHYDRATE
Product Characteristics
Color white Score no score
Shape ROUND Size 5mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-377-03 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 125 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC This package is contained within the CARTON (59779-377-03)
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 Operations
HOMEOLAB USA INC 202032533 manufacture (59779-377)

Revised: 02/2014 CVS PHARMACY

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