BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME- 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
Hyland's

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.

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Hyland's Baby Mucus + Cold Relief Daytime & Nighttime

Relieves mucus, congestion, cough, runny nose, sneezing and occasional sleeplessness

DAYTIME

Drug Facts

Active ingredients	Purpose
Bryonia Alba 6X HPUS	stubborn mucus in throat, cough with 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 mucus, chest congestion
Pulsatilla 6X HPUS	accumulation of mucus, discharge of 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 Pharmacopoeia of the United States.

Uses

■ Temporarily relieves symptoms of common cold in children, including:
■ accumulation of mucus in chest, throat or nose
■ cough with mucus ■ runny nose ■ sneezing
■ nasal or chest congestion

Warnings

Consult a physician if:

■ symptoms persist for more than 72 hours 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, 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. 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

■ Shake well before using.
■ Measure only with the dosing syringe provided.
■ Do not use dosing syringe with other products.
■ On dosing syringe, mL = milliliter.

Drug Facts (continued)

Children under

6 months

Consult a physician.

Children 6 months
to under 1 year

2.5 mL up to 4 times per day
(every 6 hours).

Children 1 year
to 3 years

5 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	Purpose
Allium Cepa 6X HPUS	runny nose with mucus, hacking cough, sore throat
Bryonia Alba 6X HPUS	stubborn mucus in throat, cough with mucus
Chamomilla 3X HPUS	occasional sleeplessness
Coffea Cruda 3X HPUS	occasional sleeplessness
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 mucus, chest congestion
Pulsatilla 6X HPUS	accumulation of mucus, discharge of mucus, loose cough
Rumex Crispus 6X HPUS	runny nose, sneezing
Silicea 12X HPUS	nasal congestion
Sulfur 12X HPUS	cough with thick mucus, chest congestion, nasal congestion

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses

■ Temporarily relieves symptoms of common cold in children at night, including:
■ accumulation of mucus in chest, throat or nose
■ cough with mucus  runny nose  sneezing
■ nasal or chest congestion
■ occasional sleeplessness

Drug Facts (continued)

Warnings

Consult a physician if:

■ symptoms persist for more than 72 hours 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, 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.

In case of emergency or accidental overdose, 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

■ Shake well before using.

■ Measure only with the dosing syringe provided.

■ Do not use dosing syringe with other products.

■ On dosing syringe, mL = milliliter.

Children under

6 months

Consult a physician.

Children 6 months

to under 1 year

2.5 mL at bedtime and every 6 hours

during the night until relieved.

Children 1 year

to 3 years

5 mL at bedtime and every 4 hours

during the night until relieved.

Other information

Inactive ingredients

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

Questions or comments?

(800) 624-9659

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

PRIMARY DISPLAY PANEL - Day & Night Value Pack Kit

VALUE PACK

HOMEOPATHIC

NDC 54973-3374-1

MONTHS

NEW

LOOK

BABY

SINCE 1903

Hyland's

Mucus + Cold Relief*

Daytime

Relieves congestion,

runny nose, cough and

loosens mucus

Nighttime

Relieves mucus, congestion,

cough, runny nose, sneezing

and occasional sleeplessness

NO PARABENS, SUGAR or DYES

NO ALCOHOL (DAY), LESS THAN 0.2% ALCOHOL (NIGHT)

NATURAL

RELIEF

TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)

TOTAL 8 FL. OZ. (236 mL)

*SEE NOTE ON SIDE

PANEL BELOW DRUG FACTS

carton

BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME
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	118 mL

Part 1 of 2

BABY MUCUS PLUS 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
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
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

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

Part 2 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; 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

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

Labeler - Hyland's (028570695)

Registrant - Standard Homeopathic Company (Hyland's) (008316655)

Name	Address	ID/FEI	Business Operations
Establishment
LGM Pharma Solutions, LLC		117549198	manufacture(54973-3374) , pack(54973-3374) , label(54973-3374)

Revised: 9/2021

Document Id: cbf8ac5d-60cb-6d94-e053-2a95a90ab128

Set id: 7979fc6f-6d2c-56c9-e053-2991aa0ac1f3

Version: 3

Effective Time: 20210914

Hyland's