CHILDRENS COLD AND MUCUS DAY AND NIGHT TWIN PACK kit

Childrens Cold and Mucus Day and Night Twin Pack by

Drug Labeling and Warnings

Childrens Cold and Mucus 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

• Bryonia Alba 6X HPUS:

  stubborn mucus in throat,cough with yellowish mucus

• Euphrasia Officinalis 6X HPUS:

  cough with mucus in chest

• Hepar Sulph Calc 12X HPUS:

  HPUS...cough up mucus, mucus rattle with cough, stubborn mucus in chest

• Natrum Muriaticum 30X HPUS:

  accumulation of mucus in throat, cough up mucus

• Phosphorus 30X HPUS:

  cough with expectoration of yellow mucus, chest congestion

• Pulsatilla 6X HPUS:

  accumulation of mucus, discharge of thick yellowish mucus, loose cough

• Rumex Crispus 6X HPUS:

  runny nose, sneezing

• Silicea 12X HPUS:

  nasal congestion

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

Temporarily relieves symptoms of colds, including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing and nasal 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 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.

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.

In case of emergency or accidental overdose,

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.

• Children 2 years to under 6 years:

  5mL or 1 teaspoon up to 6 times per day (every 4 hours)

• Children 6 years to under 12 years:

  10mL or 2 teaspoons up to 6 times per day (every 4 hours)

• Adults and children 12 years and over:

  15mL or 3 teaspoons up to 6 times per day (every 4 hours)

Inactive ingredients

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

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.

NIGHTTIME

Drug Facts

• Active ingredients:

  Purpose

• Allium Cepa 6X HPUS:

  runny nose with mucus, hacking cough, sore throat

• Bryonia Alba 6X HPUS:

  stubborn mucus in throat, cough with yellowish mucus

• Chamomilla 3X HPUS:

  irritability, fussiness, occasional sleeplessness

• Coffea Cruda 3X HPUS:

  occasional sleeplessness, restlessness

• Euphrasia Officinalis 6X HPUS:

  cough with mucus in chest

• Hepar Sulph Calc 12X HPUS:

  cough up mucus, mucus rattle with cough, stubborn mucus in chest

• Hydrastis 6X HPUS:

  cough with mucus, dry, sore throat, occasional sleeplessness due to mucus in throat

• Natrum Muriaticum 6X HPUS:

  accumulation of mucus in throat, cough up mucus

• Phosphorus 30X HPUS:

  cough with expectoration of yellow mucus, chest congestion

• Pulsatilla 6X HPUS:

  accumulation of mucus, discharge of thick yellowish mucus, loose cough

• Rumex Crispus 6X HPUS:

  runny nose, sneezing

• Silicea 12X HPUS:

  nasal congestion

• Sulphur 12X HPUS:

  cough with thick mucus, chest congestion, nasal congestion

“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 in children especially at night including accumulation of mucus in chest, throat and nose, cough with mucus, runny nose, sneezing, nasal congestion and 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.

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.

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 or 1 teaspoon at bedtime and every 4 hours during the night or as necessary

• Children 6 years to under 12 years:

  10mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary

• Adults and children 12 years and over:

  15mL or 3 teaspoons 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.

Principal Display Panel - Kit Carton

VALUE PACK

Equate™

NDC: 49035-924-01

Compare to

Hyland’s 4 Kids

Cold ‘n Mucus

Value Pack

active

ingredients

Children's

Alcohol free, Sugar free, Dye-Free

Homeopathic

Cold & Mucus*

Daytime

Ages 2 to 12 years

For Temporary Relief of:

• Mucus & congestion
• Runny nose
• 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

Less than 0.2% Alcohol, Sugar free, Dye free

Homeopathic

Cold & Mucus*

Nighttime

Ages 2 to 12 years

For Temporary Relief of:

• Mucus & congestion
• Occasional sleeplessness
• Runny nose
• 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 MUCUS DAY AND NIGHT TWIN PACK 
childrens cold and mucus day and night twin pack kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-924

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-924-01	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

COLD AND MUCUS 
bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide liquid

Product Information
Item Code (Source)	NDC: 49035-926
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [hp_X]  in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	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	30 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	6 [hp_X]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C)	RUMEX CRISPUS ROOT	6 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	30 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-926-01	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

Part 2 of 2

CHILDRENS NIGHTTIME COLD AND MUCUS 
onion, bryonia alba root, arabica coffee bean, rumex crispus root, goldenseal, anemone pulsatilla, calcium sulfide, sulfur, phosphorus, matricaria chamomilla, euphrasia stricta, sodium chloride and silicon dioxide liquid

Product Information
Item Code (Source)	NDC: 49035-922
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
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	3 [hp_X]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C)	RUMEX CRISPUS ROOT	6 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	6 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	3 [hp_X]  in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	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
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	30 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LICORICE (UNII: 61ZBX54883)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-922-01	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

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(49035-924)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc.		079424083	manufacture(49035-924) , pack(49035-924) , label(49035-924)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		876754375	manufacture(49035-924) , pack(49035-924) , label(49035-924)