BABY TINY COLD DAYTIME AND NIGHTTIME- eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, potassium iodide, and matricaria recutita 
Hyland's Inc.

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.

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Baby Tiny Cold Tablets Combo Pack

DAYTIME

Drug Facts

Active ingredientsPurpose
Eupatorium Perfoliatum 6X HPUSheadache, cough, sneezing
Euphrasia Officinalis 6X HPUSrunny eyes/nose
Gelsemium Sempervirens 6X HPUSsneezing, nasal congestion
Kali Iodatum 6X HPUSheadache, runny eyes/nose

"HPUS” is the Homeopathic Pharmacopoeia of the United States.

Uses

■ Helps temporarily relieve symptoms of common cold in children, including: ■ runny nose or eyes ■ nasal congestion ■ headache ■ sneezing ■ cough

Warnings

Ask a doctor before use if you have

■ persistent or chronic cough such as asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if

■ symptoms persist for more than 72 hours or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

Keep out of reach of children

Directions

■ Use as directed.

Children under 6 months:Ask a doctor before use.
Children 6 months to under 1 year:At onset of symptoms, dissolve 2 tablets on tongue every hour
up to 4 hours. If symptoms persist, 2 tablets every 4 hours until relieved.
Children 1 year to under 3 years:At onset of symptoms, dissolve 3 tablets on tongue every hour
up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved.

Inactive ingredients

Acacia Gum, Lactose.

NIGHTTIME

Drug Facts

Active ingredientsPurpose
Chamomilla 6X HPUSoccasional sleeplessness
Eupatorium Perfoliatum 6X HPUSheadache, cough, sneezing
Euphrasia Officinalis 6X HPUSrunny eyes/nose, nighttime coughing
Gelsemium Sempervirens 6X HPUSsneezing, nasal congestion
Kali Iodatum 6X HPUSheadache, runny eyes/nose

"HPUS” is the Homeopathic Pharmacopoeia of the United States.

Uses

■ Helps temporarily relieve symptoms of common cold in children at night, including:
■ runny nose or eyes ■ cough ■ nasal congestion
■ headache ■ sneezing ■ occasional sleeplessness

NIGHTTIME
Drug Facts
(continued)

Warnings

Ask a doctor before use if you have

■ persistent or chronic cough such as asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if

■ symptoms persist for more than 72 hours or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to
recur or is accompanied by a fever, rash or persistent headache.

Keep out of reach of children

Directions

■ Use as directed

Children under 6 months:Ask a doctor before use.
Children 6 months to under 1 year:At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours as needed. If symptoms persist, 2 tablets every 4 hours during the night until relieved.
Children 1 year to under 3 years:At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist, 3 tablets every 4 hours during the night until relieved.

Inactive ingredients

Acacia Gum, Lactose.

Questions?

www.hylands.com or care@hylands.com

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

Helps temporarily relieve symptoms of common cold in children at night, including: runny nose or eyes, cough, nasal congestion,
headache, sneezing, occasional sleeplessness.

Principal Display Panel

Hyland's

NATURALS

•baby•

Tiny Cold Tablets*

COMBO PACK

NO ARTIFICIAL FLAVORS, PARABENS or DYES

DAYTIME

Nasal Congestion

Runny Nose

Sneezing

Cough

NIGHTTIME

Sleeplessness

Nasal Congestion

Runny Nose

Sneezing

Cough

6+ MONTHS

2 x 125 CT BOTTLES

(1 DAY, 1 NIGHT)

QUICK-DISSOLVING TABLETS

HOMEOPATHIC

Carton

BABY TINY COLD DAYTIME AND NIGHTTIME 
eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, potassium iodide, and matricaria recutita kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3307
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3307-11 in 1 CARTON01/11/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 125 
Part 21 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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE6 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
ACACIA (UNII: 5C5403N26O)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize5mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3158-11 in 1 CARTON
1125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/28/2015
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_X]
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP6 [hp_X]
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE6 [hp_X]
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize5mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3252-11 in 1 CARTON
1125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/28/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/11/2017
Labeler - Hyland's Inc. (008316655)
Establishment
NameAddressID/FEIBusiness Operations
Hyland's Inc008316655manufacture(54973-3307) , pack(54973-3307) , label(54973-3307)

Revised: 11/2022
Document Id: ee8fb0c2-2a21-f92f-e053-2a95a90a8d16
Set id: be7cff09-ecff-48bd-96d4-dc7d47db7656
Version: 7
Effective Time: 20221128
 
Hyland's Inc.