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

4 Kids Cold and Cough Day and Night Grape Flavor by

Drug Labeling and Warnings

4 Kids Cold and Cough Day and Night Grape Flavor by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc., Applied Laboratories, 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 Pharmacopœia 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, post nasal drip

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

Uses

• Temporarily relieves symptoms of common cold in children, including:
• runny nose 
• sore throat 
• sneezing
• cough 
• post nasal drip
• nasal or chest congestion

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.

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.

In case of emergency or accidental overdose, 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

• 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 2 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)

Other information

• Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

• The inner packaged bottle is child-resistant.

• Store at room temperature.

• Do not refrigerate.

Inactive ingredients

Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, 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 Pharmacopœia 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, post nasal drip

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

Uses

• Temporarily relieves symptoms of common cold in children especially at night, including:
• cough 
• runny nose 
• post nasal drip
• sneezing 
• nasal or chest congestion
• 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 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.

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.

In case of emergency or accidental overdose, 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

• 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 2 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

Other information

• Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
• The inner packaged bottle is child-resistant.
• Store at room temperature.
• Do not refrigerate.

Inactive ingredients

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

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - KIT CARTON

NDC: 54973-3379-1

HOMEOPATHIC

Ages

2-12

NATURAL

RELIEF

SINCE 1903

Hyland's

4 Kids

Cold 'n Cough*

Natural Grape Flavor

Day & Night Value Pack

DAYTIME

Congestion

Runny Nose

Sore Throat

Sneezing

Cough

+ also relieves

Post Nasal Drip

ALCOHOL FREE

SUGAR FREE

DYE FREE

4 FL. OZ. (118 mL) Daytime

NIGHTTIME

Congestion

Occasional Sleeplessness

Runny Nose

Sore Throat

Sneezing

Cough

+ also relieves

Post Nasal Drip

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 GRAPE FLAVOR 
onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3379

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3379-1	1 in 1 CARTON; Type 0: Not a Combination Product	12/01/2018

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

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

Product Information
Item Code (Source)	NDC: 54973-3243
Route of Administration	ORAL

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

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

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3243-1	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		02/10/2016

Part 2 of 2

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

Product Information
Item Code (Source)	NDC: 54973-3377
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mL
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
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	6 [hp_X]  in 1 mL
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
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL

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

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3377-1	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		11/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/01/2018

Labeler - Hyland's Inc. (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3379)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc		876754375	manufacture(54973-3379) , pack(54973-3379) , label(54973-3379)