4 KIDS COLD N COUGH DAY AND NIGHT VALUE PACK- onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, goldenseal, strychnos nux-vomica seed, coffee bean, and chamomile kit

4 KIDS COLD N COUGH DAY AND NIGHT VALUE PACK by

Drug Labeling and Warnings

4 KIDS COLD N COUGH DAY AND NIGHT VALUE PACK by is a Homeopathic medication manufactured, distributed, or labeled by Hylands Inc., Standard Homeopathic Company, LGM Pharma Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, nasal congestion
• Sulphur 12X HPUS: chest congestion, nasal congestion, sneezing, runny nose

"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

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 high fever (101°F)
• Cough tends to recur or is accompanied by 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 a 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 band is broken or missing.

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, 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 USP, Glycyrrhiza Extract, Purified Water USP, Sodium Benzoate N.F., Vegetable Glycerine USP.

NIGHTTIME Drug Facts

• Active ingredients: 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
• Nux Vomica 6X HPUS: tired, difficulty falling asleep, frequent waking
• 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

"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States

Uses

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

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 high fever (101°F)
• Cough tends to recur or is accompanied by 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 a 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 band is broken or missing.

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, 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

PRINCIPAL DISPLAY PANEL - Kit Carton

Natural
Relief

NDC: 54973-3177-1
HOMEOPATHIC*

Ages
2-12

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 N COUGH DAY AND NIGHT VALUE PACK 
onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, goldenseal, strychnos nux-vomica seed, coffee bean, and chamomile kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3177

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3177-1	1 in 1 CARTON; Type 0: Not a Combination Product	12/01/2013

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
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [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
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
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

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

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

NIGHTTIME COLD N COUGH 4 KIDS 
onion, coffee bean, chamomile, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, and sulfur liquid

Product Information
Item Code (Source)	NDC: 54973-3098
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
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
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_X]  in 1 mL
COFFEE BEAN (UNII: JFH385Y744) (COFFEE BEAN - UNII:JFH385Y744)	COFFEE BEAN	6 [hp_X]  in 1 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3098-1	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		07/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/01/2013

Labeler - Hylands Inc. (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3177) , pack(54973-3177)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, INC		079424083	manufacture(54973-3177) , pack(54973-3177) , label(54973-3177)