KIDS COLD AND COUGH COMBO PACK- onion, chamomile, arabica coffee bean, calcium sulfide, golden seal, sodium chloride, phosphorus, pulsatilla vulgaris top, sulfur 
Hyland's Consumer Health 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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Hyland's Naturals Kids Cold & Cough Combo Pack Grape Flavor

Sleeplessness, Congestion, Runny Nose, Sore Throat, Cough, Post Nasal Drip

DAYTIME

Drug Facts

Active ingredientsPurpose*
Allium Cepa 6X HPUS ............................... ...................................................watery/runny nose, cold, hacking cough, painful throat
Hepar Sulph Calc 12X HPUS.........................................................................cold, sneezing
Hydrastis 6X HPUS.......................................................................................rattling/tickling cough, sinus congestion, dry/raw/sore throat
Natrum Muriaticum 6X HPUS.......................................................................dry cough, sore throat
Phosphorus 12X HPUS ...............................................................................hoarse/dry cough, nasal congestion, chest congestion
Pulsatilla 6X HPUS .....................................................................................moist cough, cold, post nasal drip
Sulphur 12X HPUS.....................................................................................chest congestion, nasal congestion, sneezing, runny nose

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

Uses*

■ Helps temporarily relieve symptoms of common cold in children, including:
■ runny nose ■ sore throat ■ sneezing ■ cough
■ post nasal drip ■ nasal or chest congestion

Warnings

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask a doctor before use if you have

■ persistent or chronic cough such as smoking, 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 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

If pregnant or breastfeeding

ask a health professional before use.

Keep out of reach of children

Directions

■ Use as directed. ■ Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing cup provided. ■ Do not use dosing cup with other products. ■ On dosing cup, mL = milliliter.

Children 4 years
to under 6 years
5 mL up to 6 times per day
(every 4 hours).
Children 6 years
to under 12 years
10 mL up to 6 times per day
(every 4 hours).
Adults and children
12 years and over
15 mL up to 6 times per day
(every 4 hours).

Inactive ingredients

Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, Purified Water, Sodium Benzoate.

NIGHTTIME

Drug Facts

Active ingredientsPurpose*
Allium Cepa 6X HPUS ....................................................................................watery/runny nose, cold, hacking cough, painful throat
Chamomilla 6X HPUS.....................................................................................occasional sleeplessness
Coffea Cruda 6X HPUS .................................................................................occasional sleeplessness
Hepar Sulph Calc 12X HPUS........................................................................cold, sneezing
Hydrastis 6X HPUS.......................................................................................rattling/tickling cough, sinus congestion, dry/raw/sore throat
Natrum Muriaticum 6X HPUS.......................................................................dry cough, sore throat
Phosphorus 12X HPUS .............................................................................. hoarse/dry cough, nasal congestion, chest congestion
Pulsatilla 6X HPUS ..................................................................................... moist cough, cold, post nasal drip
Sulphur 12X HPUS......................................................................................chest congestion, nasal congestion, sneezing, runny nose

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

Uses*

■ Helps temporarily relieve symptoms of common cold in children at night, including:
■ cough ■ runny nose ■ post nasal drip ■ sneezing ■ sore throat
■ nasal or chest congestion ■ occasional sleeplessness

Warnings

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask a doctor before use if you have

■ persistent or chronic cough such as smoking, 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 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

If pregnant or breastfeeding

Ask a health professional before use.

Keep out of reach of children

Directions

■ Use as directed. ■ Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing cup provided. ■ Do not use
dosing cup with other products. ■ On dosing cup, mL = milliliter.

Children 4 years
to under 6 years
5 mL at bedtime and every 4 hours
during the night until relieved.
Children 6 years
to under 12 years
10 mL at bedtime and every 4 hours
during the night until relieved.
Adults and children
12 years and over
15 mL at bedtime and every 4 hours
during the night until relieved.

Inactive ingredients

Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, Purified Water, Sodium Benzoate.

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.

Principal Display Panel

Hyland's

NATURALS™

Cold & Cough*

COMBO PACK

NO ALCOHOL, SUGAR, PARABENS or DYES

DAYTIMENIGHTTIME
Congestion*

Sleeplessness*

Runny Nose*Congestion*
Sore Throat*Runny Nose*
Cough*Sore Throat*
Post Nasal Drip*Cough*
Post Nasal Drip*

4 - 12 YEARS

NATURAL

GRAPE FLAVOR

TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)

HOMEOPATHIC

carton

KIDS COLD AND COUGH COMBO PACK 
onion, chamomile, arabica coffee bean, calcium sulfide, golden seal, sodium chloride, phosphorus, pulsatilla vulgaris top, sulfur kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4112
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-4112-11 in 1 KIT; Type 0: Not a Combination Product12/01/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 118 mL
Part 21 BOTTLE, PLASTIC 118 mL
Part 1 of 2
KIDS COLD AND COUGH NIGHTTIME GRAPE FLAVOR 
onion, chamomile, arabica coffee bean, calcium sulfide, golden seal, sodium chloride, phosphorus, pulsatilla vulgaris top, sulfur liquid
Product Information
Item Code (Source)NDC:54973-4111
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE6 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 mL
PULSATILLA VULGARIS TOP (UNII: 4F1D271XW0) (PULSATILLA VULGARIS TOP - UNII:4F1D271XW0) PULSATILLA VULGARIS TOP6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Natural Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-4111-11 in 1 CARTON
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/01/2022
Part 2 of 2
KIDS COLD AND COUGH DAYTIME GRAPE FLAVOR 
onion, calcium sulfide, golden seal, sodium chloride, phosphorus, pulsatilla vulgaris whole, sulfur liquid
Product Information
Item Code (Source)NDC:54973-4110
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (PULSATILLA VULGARIS WHOLE - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Natural Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-4110-11 in 1 CARTON
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/01/2022
Labeler - Hyland's Consumer Health Inc. (008316655)
Establishment
NameAddressID/FEIBusiness Operations
Hyland's Inc.008316655manufacture(54973-4112) , pack(54973-4112) , label(54973-4112)

Revised: 9/2023
Document Id: 05f92b70-2d18-1bcf-e063-6294a90aba07
Set id: e6ffd6d1-fcfb-547d-e053-2995a90af9b6
Version: 2
Effective Time: 20230922
 
Hyland's Consumer Health Inc.