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

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.

----------

Baby Tiny Cold Day and Night Value Pack

DAYTIME

Drug Facts

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.

NIGHTTIME

Drug Facts

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

PRINCIPAL DISPLAY PANEL - Kit Carton
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)

Revised: 1/2017
Document Id: d73ea3fb-3486-400e-8e1f-23b29a9701d6
Set id: be7cff09-ecff-48bd-96d4-dc7d47db7656
Version: 1
Effective Time: 20170113
 
Hyland's