BABY TINY COLD DAY AND NIGHT VALUE PACK- eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, potassium iodide, and matricaria recutita kit

Baby Tiny Cold Daytime and Nighttime by

Drug Labeling and Warnings

Baby Tiny Cold Daytime and Nighttime by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc., Hyland's Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DAYTIME

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopæia 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 persist 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 Baby Tiny Cold Tablets are very soft and will dissolve almost instantly in the mouth.

Inactive ingredients

Acacia Gum, Lactose.

SPL UNCLASSIFIED SECTION

NIGHTTIME

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopæia of the United States.
Chamomilla 6X HPUS	occasional sleeplessness
Eupatorium Perfoliatum 6X HPUS	headache, cough, sneezing
Euphrasia Officinalis 6X HPUS	runny eyes, nose and nighttime coughing
Gelsemium Sempervirens 6X HPUS	sneezing with stuffy nose and occasional sleeplessness
Kali Iodatum 6X HPUS	headache, runny eyes & nose and occasional sleeplessness

Uses

Temporarily relieves the symptoms of runny nose and eyes, nighttime cough, congestion, headache, sneezing and occasional sleeplessness due to common head colds in children.

Warnings

Consult a physician if:

• symptoms persist 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 4 hours during the night as required.

Children 1 to 3 years of age: dissolve 3 tablets on tongue every 4 hours during the night as required.

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

Inactive ingredients

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - Kit Carton

Day
& Night
Value Pack

SINCE 1903
Hyland's®
Baby

NDC: 54973-3307-1
HOMEOPATHIC
Ages 6 months+

Natural
Relief

Daytime
Tiny Cold
Tablets

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

Nighttime
Tiny Cold
Tablets

RELIEF OF RUNNY NOSE,
CONGESTION, AND
OCCASIONAL SLEEPLESSNESS
DUE TO COLDS*

‣ No Artificial Flavors, Dyes or Parabens

2 Bottles of 125 Quick-Dissolving Tablets / 250 Tablets Total

INGREDIENTS AND APPEARANCE

BABY TINY COLD DAY AND NIGHT VALUE PACK 
eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, potassium iodide, and matricaria recutita kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3307

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3307-1	1 in 1 CARTON	01/11/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	125
Part 2	1 BOTTLE, PLASTIC	125

Part 1 of 2

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

Product Information
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, UNSPECIFIED FORM (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	125 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		12/28/2015

Part 2 of 2

BABY NIGHTTIME TINY COLD 
matricaria recutita, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide tablet

Product Information
Item Code (Source)	NDC: 54973-3252
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	6 [hp_X]
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
ACACIA (UNII: 5C5403N26O)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)

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: 54973-3252-1	125 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		12/28/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		01/11/2017

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	MANUFACTURE(54973-3307) , PACK(54973-3307) , LABEL(54973-3307)