BABY MUCUS PLUS COLD RELIEF DAY AND NIGHT VALUE PACK- calcium sulfide,phosphorus,sulfur,rumex crispus root,sodium chloride,arabica coffee bean,anemone pulsatilla,silicon dioxide, goldenseal,onion,bryonia alba root,euphrasia stricta and matricaria chamomilla kit

Drug Details [pdf]

DAYTIME

Drug Facts

Active ingredients

Bryonia Alba 6X HPUS

Euphrasia Officinalis 6X HPUS

Hepar Sulph Calc 12X HPUS

Natrum Muriaticum 30X HPUS

Phosphorus 30X HPUS

Pulsatilla 6X HPUS

Rumex Crispus 6X HPUS

Silicea 12X HPUS

“HPUS” indicates that the active ingredients are in the

official Homeopathic Pharmacopœia of the United States.

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......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

Uses

Temporarily relieves the symptoms of colds, including: accumulation of mucus in chest, throat and nose cough with mucus 

runny nose  sneezing nasal congestion

Warnings

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, 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-evident bottle cap band is broken or missing.

The inner packaged bottle is child-resistant

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 syringe provided

Do not use dosing syringe with other products

On dosing syringe, mL = milliliter, tsp = teaspoon

Drug Facts (continued)

Children under

6 months of age

consult a licensed health care

professional before using this

product

Children 6 months to

under 1 year of age

2.5 mL or ½ tsp up to

4 times daily (every 6 hours)

Children 1 to 3

years of age

5 mL or 1 tsp up to

6 times daily (every 4 hours)

Inactive ingredients

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

NIGHTTIME

Active ingredients

Allium Cepa 6X HPUS

Bryonia Alba 6X HPUS

Chamomilla 3X HPUS

Coffea Cruda 3X HPUS

Euphrasia Officinalis 6X HPUS

Hepar Sulph Calc 12X HPUS

Hydrastis 6X HPUS

Natrum Muriaticum 6X HPUS

Phosphorus 30X HPUS

Pulsatilla 6X HPUS

Rumex Crispus 6X HPUS

Silicea 12X HPUS

Sulphur 12X HPUS

“HPUS” indicates that the active ingredients are in the

official Homeopathic Pharmacopœia of the United States.

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 and sneezing

Silicea 12X HPUS.....................................nasal congestion

Sulphur 12X HPUS...............cough with thick mucus, chest congestion, nasal congestion

Uses

Temporarily relieves the symptoms of colds,including: accumulation of mucus in chest, throat and nose cough with mucus 

runny nose sneezing nasal congestion irritability fussiness occasional sleeplessness

Drug Facts (continued)

Warnings

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 Poison Control Center immediately.

Do not use this product for

persistent or chronic cough such as asthma, smoking, emphysema or if cough is accompanied by excessive mucus, unles 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-evident bottle cap band is broken or missing.

The inner packaged bottle is child-resistant.

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 syringe provided
Do not use dosing syringe with other products
On dosing syringe, mL = milliliter, tsp = teaspoon

Children under

6 months of age

consult a licensed health care professional

before using this product

Children 6 months to

under 1 year of age

2.5 mL or ½ tsp at bedtime and every

6 hours during the night or as necessary

Children 1 to 3

years of age

5 mL or 1 tsp 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

SPL UNCLASSIFIED SECTION

*CLAIMS BASED ON TRADITIONAL

HOMEOPATHIC PRACTICE, NOT ACCEPTED

MEDICAL EVIDENCE. NOT FDA EVALUATED.
PRIMARY DISPLAY PANEL - Day & Night Value Pack Kit

NDC: 54973-3374-1

HOMEOPATHIC

Ages

6 months+

NATURAL

RELIEF

SINCE 1903

Hyland's

baby

Mucus + Cold Relief*

Day & Night Value Pack

Daytime

LOOSENS MUCUS,

RELIEF OF

CONGESTION,

RUNNY NOSE

AND COUGH

ALCOHOL FREE

4 FL. OZ. (118 mL) Daytime

Nighttime

LOOSENS MUCUS,

RELIEF OF

CONGESTION

AND OCCASIONAL

SLEEPLESSNESS

DUE TO COLDS

LESS THAN 0.2% ALCOHOL

4 FL. OZ. (118 mL) Nighttime

No Artificial Flavors, Dyes or Parabens

8 FL. OZ. (236 mL) TOTAL

INGREDIENTS AND APPEARANCE

BABY MUCUS PLUS COLD RELIEF DAY AND NIGHT VALUE PACK
calcium sulfide,phosphorus,sulfur,rumex crispus root,sodium chloride,arabica coffee bean,anemone pulsatilla,silicon dioxide, goldenseal,onion,bryonia alba root,euphrasia stricta and matricaria chamomilla kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3374

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 54973-3374-1	1 in 1 CARTON; Type 0: Not a Combination Product	11/01/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BOTTLE, PLASTIC	118 mL
Part 2	1 BOTTLE, PLASTIC	118 mL

Part 1 of 2

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

Product Information
Item Code (Source)	NDC: 54973-3371
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X] in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [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
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	3 [hp_X] in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X] in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C)	RUMEX CRISPUS 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
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
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	6 [hp_X] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 54973-3371-2	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		11/01/2018

Part 2 of 2

BABY MUCUS AND COLD RELIEF
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: 54973-3284
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	30 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	30 [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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [hp_X] in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_X] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 54973-3284-1	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/13/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		11/01/2018

Labeler - Hyland's (028570695)

Name	Address	ID/FEI	Business Operations
Establishment
Nexgen Pharma, Inc.		079424083	manufacture(54973-3374) , pack(54973-3374) , label(54973-3374)