Childrens Cold and Cough Day and Night Value Pack: Homeopathic Product Information

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
Walgreen Company

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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

*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.

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 Multilevel Packaging 1 NDC:0363-9998-01 1 KIT in 1 CARTON None

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 6 [hp_X] in 1 mL CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 12 [hp_X] in 1 mL SULFUR (SULFUR) SULFUR 12 [hp_X] in 1 mL PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 12 [hp_X] in 1 mL GOLDENSEAL (GOLDENSEAL) GOLDENSEAL 6 [hp_X] in 1 mL ONION (ONION) ONION 6 [hp_X] in 1 mL ANEMONE PULSATILLA (ANEMONE PULSATILLA) ANEMONE PULSATILLA 6 [hp_X] in 1 mL

Inactive Ingredients Ingredient Name Strength WATER GLYCERIN CITRIC ACID MONOHYDRATE SODIUM BENZOATE GLYCYRRHIZA GLABRA

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0363-9997-01 118 mL in 1 BOTTLE, PLASTIC None

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARABICA COFFEE BEAN (ARABICA COFFEE BEAN) ARABICA COFFEE BEAN 6 [hp_X] in 1 mL ONION (ONION) ONION 6 [hp_X] in 1 mL CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 12 [hp_X] in 1 mL PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 12 [hp_X] in 1 mL SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 6 [hp_X] in 1 mL ANEMONE PULSATILLA (ANEMONE PULSATILLA) ANEMONE PULSATILLA 6 [hp_X] in 1 mL MATRICARIA CHAMOMILLA (MATRICARIA CHAMOMILLA) MATRICARIA CHAMOMILLA 6 [hp_X] in 1 mL GOLDENSEAL (GOLDENSEAL) GOLDENSEAL 6 [hp_X] in 1 mL SULFUR (SULFUR) SULFUR 12 [hp_X] in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE GLYCYRRHIZA GLABRA GLYCERIN WATER CITRIC ACID MONOHYDRATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0363-9996-01 118 mL in 1 BOTTLE, PLASTIC None

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	Operations
Standard Homeopathic Company		008316655	manufacture (0363-9998), pack (0363-9998), label (0363-9998)

Establishment
Name	Address	ID/FEI	Operations
Standard Homeopathic Company		080253323	manufacture (0363-9998), pack (0363-9998), label (0363-9998)

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

Revised: 12/2021 Walgreen Company