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

Childrens Cold and Cough Day and Night Twin Pack by

Drug Labeling and Warnings

Childrens Cold and Cough Day and Night Twin Pack by is a Homeopathic medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc. 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, sore 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 that 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 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 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 or accidental overdose,

contact a medical professional or Poison Control

Center immediately.

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.

Drug Facts (continued)

• Children 2 years to under 6 years:

  5mL up to 6 times

  per day (every 4 hours)

• Children 6 years to under 12 years:

  10mL up to 6 times

  per day (every 4 hours)

• Adults and children 12 years and over:

  15mL 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, Glycerin, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

NIGHTTIME

Drug Facts

• Active ingredients: Purpose
• Allium Cepa 6X HPUS: watery/runny nose, cold, hacking cough, sore 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

“HPUS” indicates that 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 accompanying 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



Drug Facts (continued)

• 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 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 or accidental overdose, contact a medical professional or Poison Control Center immediately.

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: 5mL at bedtime and every 4 hours during the night

  or as necessary

• Children 6 years to under 12 years: 10mL at bedtime and every 4 hours during the night or as necessary
• Adults and children 12 years and over: 15mL at bedtime and every 4 hours during the night or as necessary

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, Glycerin, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

SPL UNCLASSIFIED SECTION

*Claims based on traditional homeopathic

practice, not accepted medical evidence.

Not FDA evaluated.

Primary Principal Display Panel - Children's Cold & Cough Day & Night Value Pack

VALUE PACK

NDC: 49035-95-01

Equate™

Compare to

Hyland’s 4 Kids

Cold ‘n Cough Day

& Night Value Pack

active ingredients

Children's

Alcohol-Free, Sugar-Free Dye-Free

Homeopathic

Cold & Cough*

Daytime

Ages 2 to12 years

For Temporary Relief of:

• Nasal congestion
• Runny nose
• Sore throat
• Sneezing
• Cough

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

4 FL OZ (118mL) Daytime

8 FL OZ (236mL) TOTAL

Children's

Alcohol-Free, Sugar-Free Dye-Free

Homeopathic

Cold & Cough*

Nighttime

Ages 2 to12 years

For Temporary Relief of:

• Chest congestion
• Occasional sleeplessness
• Runny nose
• Sore throat
• Sneezing
• Cough

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

4 FL OZ (118mL) Nighttime

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-925

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-925-01	1 in 1 CARTON; Type 0: Not a Combination Product	07/01/2018

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

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

Product Information
Item Code (Source)	NDC: 49035-920
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
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	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
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	6 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	6 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-920-01	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		07/02/2018

Part 2 of 2

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

Product Information
Item Code (Source)	NDC: 49035-927
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-927-01	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		06/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/01/2018

Labeler - Wal-Mart Stores, Inc (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(49035-925)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc.		079424083	manufacture(49035-925) , pack(49035-925) , label(49035-925)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		876754375	manufacture(49035-925) , pack(49035-925) , label(49035-925)