TINY COLD- eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide tablet, soluble

Tiny Cold by

Drug Labeling and Warnings

Tiny Cold by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's, Standard Homeopathic Company (Hyland's), Standard Homeopathic Company, Merical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Eupatorium Perfoliatum 6X HPUS	headache, cough, sneezing
Euphrasia Officinalis 6X HPUS	runny eyes & nose
Gelsemium Sempervirens 6X HPUS	sneezing with stuffy nose
Kali Iodatum 6X HPUS	headache, runny eyes & nose

Uses

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

Warnings

Consult a physician if:

• symptoms persists for more than 72 hours or worsen
• symptoms are accompanied by a high fever (over 101°F).

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or poison control center immediately.

Do not use if imprinted tamper band is broken or missing.

In case of emergency, contact a medical professional or poison control center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

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 tongue every 15 minutes for 4 doses, then hourly until relieved.

Children 1 to 3 years of age

Dissolve 3 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

Hyland's Tiny Cold Tablets are very soft and will dissolve almost instantly in the mouth.

Inactive Ingredients

Acacia Gum, Lactose

PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton

NDC: 54973-3158-1
HOMEOPATHIC*

Ages

6 months+

SINCE 1903
Hyland's®
Baby

Natural
Relief

Tiny Cold
Tablets

RELIEF OF RUNNY NOSE,
CONGESTION AND
SNEEZING DUE TO COLDS*

▸ No Artificial Flavors, Dyes or Parabens

ACTUAL SIZE 65 MG

125 QUICK-DISSOLVING TABLETS

INGREDIENTS AND APPEARANCE

TINY COLD 
eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide tablet, soluble

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3158
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
ACACIA (UNII: 5C5403N26O)

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: 54973-3158-1	1 in 1 CARTON	12/28/2011
1		125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-3158-4	6 in 1 PACKET; Type 0: Not a Combination Product	12/28/2011
3	NDC: 54973-3158-2	1 in 1 CARTON	12/28/2011
3		135 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/28/2011

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3158)

Establishment
Name	Address	ID/FEI	Business Operations
Merical, Inc.		029644978	manufacture(54973-3158)