4 KIDS COLD AND COUGH DAY AND NIGHT VALUE PACK- onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal kit

4 Kids Cold and Cough Daytime and Nighttime by

Drug Labeling and Warnings

4 Kids Cold and Cough Daytime and Nighttime by is a Homeopathic medication manufactured, distributed, or labeled by Hyland’s Inc., Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DAYTIME

Drug Facts

Active ingredients

Allium Cepa 6X HPUS

Hepar Sulph Calc 12X HPUS

Hydrastis 6X HPUS

Natrum Muriaticum 6X HPUS

Phosphorus 12X HPUS

Pulsatilla 6X HPUS

Sulphur 12X HPUS

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

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, nasal congestion

Sulphur 12X HPUS......................chest congestion, nasal congestion, sneezing, runny nose

Uses

Temporarily relieves the symptoms of the common cold including nasal and chest congestion, runny nose, sore throat, sneezing and cough.

Warnings

As with any drug, ask a doctor before use if pregnant

or breast-feeding.

Consult a physician if

symptoms persist for more than 7 days or worsen.

inflammation, fever or infection develops.

symptoms are accompanied by a high fever (over 101°F).

cough tends to recur or is accompanied by a high fever,

rash or persistent headache.

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 this product

For persistent or chronic cough such as asthma, smoking or emphysema or if cough is

accompanied by excessive mucus, unless directed by a licensed health care professional.

Persistent cough

A persistent cough may be a sign of a serious condition.

Sore throat warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly.

Do not use if imprinted tamper-evident bottle band is

broken or missing.

The inner packaged bottle is child-resistant. 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.

Drug Facts (continued)

Directions

• Measure only with the dosing cup provided
• Do not use dosing cup with other products
• On dosing cup, mL = milliliter, tsp = teaspoon

• Children 2 years to under 6 years: 5 mL or 1 teaspoon up to

  6 times per day (every 4 hours)

• Children 6 years to under 12 years:

  10 mL or 2 teaspoons up to

  6 times per day (every 4 hours)

• Adults and children 12 years and over:

  15 mL or 3 teaspoons up to

  6 times per day (every 4 hours)

Inactive ingredients

Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

NIGHTTIME

Drug Facts

Active ingredients

Allium Cepa 6X HPUS

Chamomilla 6X HPUS

Coffea Cruda 6X HPUS

Hepar Sulph Calc 12X HPUS

Hydrastis 6X HPUS

Natrum Muriaticum 6X HPUS

Phosphorus 12X HPUS

Pulsatilla 6X HPUS

Sulphur 12X HPUS

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Purpose

Allium Cepa 6X HPUS ..........watery/runny nose, cold,hacking cough, painful throat

Chamomilla 6X HPUS ......... sensitive, irritable, fussy, nocturnal occasional sleeplessness

Coffea Cruda 6X HPUS........occasional sleeplessness, restlessness

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, nasal congestion

Sulphur 12X HPUS .........................chest congestion,nasal congestion, sneezing, runny nose

Uses

Temporarily relieves the symptoms of the common cold including cough, runny nose,

sneezing, nasal and chest congestion, and sore throat with accompanying occasional sleeplessness.

Warnings

As with any drug, ask a doctor before use if

pregnant or breast-feeding.

Drug Facts (continued)

Consult a physician

• symptoms persist for more than 7 days or worsen.
• inflammation, fever or infection develops.
• symptoms are accompanied by a high fever (over 101°F).
• cough tends to recur or is accompanied by a high fever,rash or persistent headache.

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 this product

for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional.

A persistent cough may be a sign of a serious condition.

Sore throat warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea,and vomiting may be serious. Consult a doctor promptly.

Do not use if imprinted tamper-evident bottle band is

broken or missing.

The inner packaged bottle is child-resistant. 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

• Measure only with the dosing cup provided
• Do not use dosing cup with other products
• On dosing cup, mL = milliliter, tsp = teaspoon

• Children 2 years to under 6 years:

  5 mL or 1 teaspoon at bedtime

  and every 4 hours during the

  night or as necessary

• Children 6 years to under 12 years: 10 mL or 2 teaspoons at

  bedtime and every 4 hours

  during the night or as necessary

• Adults and children 12 years and over:

  15 mL or 3 teaspoons at

  bedtime and every 4 hours

  during the night or as necessary

Inactive ingredients

Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

Questions or comments?

(800) 624-9659

SPL UNCLASSIFIED SECTION

*CLAIMS BASED ON TRADITIONAL

HOMEOPATHIC PRACTICE, NOT ACCEPTED

MEDICAL EVIDENCE. NOT FDA EVALUATED.

Principal Display Panel - Kit Carton

NDC-54973-3378-1

HOMEOPATHIC

NATURAL

RELIEF

SINCE 1903

Hyland's

4 Kids

Cold ’n Cough*

Day & Night Value Pack

DAYTIME

Nasal Congestion

Runny Nose

Sore Throat

Sneezing

Cough

ALCOHOL FREE

SUGAR FREE

DYE FREE

4 FL. OZ. (118 mL) Daytime

NIGHTTIME

Chest Congestion

Occasional Sleeplessness

Runny Nose

Sore Throat

Sneezing

Cough

ALCOHOL FREE

SUGAR FREE

DYE FREE

4 FL. OZ. (118 mL) Nighttime

8 FL. OZ. (236 mL) TOTAL

INGREDIENTS AND APPEARANCE

4 KIDS COLD AND COUGH DAY AND NIGHT VALUE PACK 
onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3378

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3378-1	1 in 1 CARTON; Type 0: Not a Combination Product	06/08/2018

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

COLD N COUGH 4 KIDS 
onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid

Product Information
Item Code (Source)	NDC: 54973-3075
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	6 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	6 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3075-1	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		08/01/2008

Part 2 of 2

4 KIDS COLD AND COUGH NIGHTTIME 
onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal liquid

Product Information
Item Code (Source)	NDC: 54973-3375
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	6 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	6 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	6 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [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)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3375-1	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		07/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/08/2018

Labeler - Hyland’s (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc.		079424083	manufacture(54973-3378) , pack(54973-3378) , label(54973-3378)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		876754375	manufacture(54973-3378) , pack(54973-3378) , label(54973-3378)