KIDS COLD AND COUGH COMBO PACK- onion, chamomile, arabica coffee bean, calcium sulfide, golden seal, sodium chloride, phosphorus, pulsatilla vulgaris top, sulfur kit

Kids Cold and Cough Combo Pack by

Drug Labeling and Warnings

Kids Cold and Cough Combo Pack by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Consumer Health Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

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

DAYTIME

Drug Facts

• Active ingredients: Purpose*

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 ingredients: Purpose*

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

• DAYTIME: NIGHTTIME
• Congestion*:

  Sleeplessness*

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

4 - 12 YEARS

NATURAL

GRAPE FLAVOR

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

HOMEOPATHIC

INGREDIENTS AND APPEARANCE

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-4112

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-4112-1	1 in 1 KIT; Type 0: Not a Combination Product	12/01/2022

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	118 mL
Part 2	1 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 Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X]  in 1 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	6 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	6 [hp_X]  in 1 mL
PULSATILLA VULGARIS TOP (UNII: 4F1D271XW0) (PULSATILLA VULGARIS TOP - UNII:4F1D271XW0)	PULSATILLA VULGARIS TOP	6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE (Natural Grape Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-4111-1	1 in 1 CARTON
1		118 mL 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		12/01/2022

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 Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [hp_X]  in 1 mL
PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (PULSATILLA VULGARIS WHOLE - UNII:I76KB35JEV)	PULSATILLA VULGARIS WHOLE	6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE (Natural Grape Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-4110-1	1 in 1 CARTON
1		118 mL 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		12/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/01/2022

Labeler - Hyland's Consumer Health Inc. (008316655)

Establishment
Name	Address	ID/FEI	Business Operations
Hyland's Inc.		008316655	manufacture(54973-4112) , pack(54973-4112) , label(54973-4112)