CHILDRENS 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

Childrens Cold and Cough Day and Night Value Pack by

Drug Labeling and Warnings

Childrens Cold and Cough Day and Night Value Pack by is a Homeopathic medication manufactured, distributed, or labeled by Walgreen Company. 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

watery/runny nose, cold,hacking cough, sore throat

cold, sneezing

rattling/tickling cough, sinus congestion, dry/raw/sore throat

dry cough, sore throat

hoarse/dry cough, nasal congestion, chest congestion

moist cough, cold, nasal congestion

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 or 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

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, contact a medical professional or Poison Control Center immediately.

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, tsp = teaspoon

• Children 2 years 5 mL to under 6 years:

  5 mL up to 6 timeshours)

  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, 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

watery/runny nose, cold, hacking cough, sore throat

sensitive, irritable, fussy, occasional sleeplessness

occasional sleeplessness, restlessness

cold, sneezing

rattling/tickling cough, sinus congestion, dry/raw/sore throat

dry cough, sore throat

hoarse/dry cough,nasal congestion, chest congestion

moist cough, cold, nasal congestion

chest congestion, nasal congestion, sneezing, runny nose

Uses

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

Drug Facts (continued)

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 medical 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, contact a medical professional or Poison Control Center immediately.

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.

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

  or as necessary

• Children 6 years to under 12 years:

  10 mL at bedtime and every

  4 hours during the night

  or as necessary

• Adults and children 12 years and over:

  15 mL 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?

1-800-925-4733

SPL UNCLASSIFIED SECTION

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE.

NOT FDA EVALUATED.

Principal Display Panel - Day & Night Pack Carton

DAY & NIGHT PACK NDC: 0363-9998-01

Walgreens

children's

DAYTIME

Dye-Free

Cold &

Cough*

DYE FREE

SUGAR FREE

ALCOHOL FREE

Homeopathic

AGES

2-12

Years

FLAVOR FREE

4 FL OZ (118 mL) DAYTIME

Compare to Hyland’s

4 Kids Cold ’n Cough

Day & Night Value Pack

NEW

children's

NIGHTTIME

Dye-Free

Cold &

Cough*

DYE FREE

SUGAR FREE

ALCOHOL FREE

Homeopathic

AGES

2-12

Years

FLAVOR FREE

4 FL OZ (118 mL) NIGHTTIME

8 FL OZ (236 mL) TOTAL

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

INGREDIENTS AND APPEARANCE

CHILDRENS 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: 0363-9998

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-9998-01	1 in 1 CARTON; Type 0: Not a Combination Product	02/01/2019

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

CHILDRENS COLD AND COUGH 
onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid

Product Information
Item Code (Source)	NDC: 0363-9997
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
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
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	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
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: 0363-9997-01	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		02/01/2019

Part 2 of 2

CHILDRENS 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: 0363-9996
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
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-9996-01	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		02/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/01/2019

Labeler - Walgreen Company (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(0363-9998) , pack(0363-9998) , label(0363-9998)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		876754375	manufacture(0363-9998) , pack(0363-9998) , label(0363-9998)