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

Baby Nighttime Tiny Cold by

Drug Labeling and Warnings

Baby Nighttime Tiny Cold by is a Homeopathic medication manufactured, distributed, or labeled by 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.
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 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 - 125 Tablet Bottle Carton

Ages

6 months+

NDC: 54973-3252-1

HOMEOPATHIC

SINCE 1903

Hyland's®

Baby

Natural

Relief

Nighttime

Tiny Cold

Tablets

RELIEF OF RUNNY NOSE,

CONGESTION, AND

OCCASIONAL SLEEPLESSNESS

DUE TO COLDS*

▶ No Artificial Flavors, Dyes or Parabens

125 QUICK-DISSOLVING TABLETS

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	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	1 in 1 CARTON	12/28/2015
1		125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-3252-2	6 in 1 PACKET; Type 0: Not a Combination Product	12/28/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/28/2015

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3252) , pack(54973-3252)

Establishment
Name	Address	ID/FEI	Business Operations
Merical, Inc.		029644978	pack(54973-3252)