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 Inc.

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 Naturals Baby Mucus + Cold Relief Combo Pack Daytime & Nighttime

DAYTIME

Drug Facts

Active ingredientsPurpose*
Bryonia Alba 6X HPUSstubborn mucus in throat, cough with mucus
Euphrasia Officinalis 6X HPUScough with mucus in chest
Hepar Sulph Calc 12X HPUScough up mucus, mucus rattle with cough, stubborn mucus in chest
Natrum Muriaticum 30X HPUSaccumulation of mucus in throat, cough up mucus
Phosphorus 30X HPUScough with mucus, chest congestion
Pulsatilla 6X HPUSaccumulation of mucus, discharge of mucus, loose cough
Rumex Crispus 6X HPUSrunny nose, sneezing
Silicea 12X HPUSnasal congestion

HPUS" is the Homeopathic Pharmacopoeia of the United States.

Uses*

■ Helps temporarily relieve 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

Ask a doctor before use if you have

■ persistent or chronic cough such as asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if

■ symptoms persist for more than 72 hours or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

Keep out of reach of children

Directions

■ Use as directed. ■ Do not refrigerate. ■ 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
Ask a doctor before use.
Children 6 months
to under 1 year
2.5 mL up to 4 times per day
(every 6 hours).
Children 1 year
to under 3 years
5 mL up to 6 times per day
(every 4 hours).

Inactive ingredients

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

NIGHTTIME

Drug Facts

Active ingredientsPurpose*
Allium Cepa 6X HPUSrunny nose with mucus, hacking cough, sore throat
Bryonia Alba 6X HPUSstubborn mucus in throat, cough with mucus
Chamomilla 3X HPUSoccasional sleeplessness
Coffea Cruda 3X HPUSoccasional sleeplessness
Euphrasia Offcinalis 6X HPUScough with mucus in chest
Hepar Sulph Calc 12X HPUScough up mucus, mucus rattle with cough, stubborn mucus in chest
Hydrastis 6X HPUScough with mucus, dry/sore throat, occasional sleeplessness due to mucus in throat
Natrum Muriaticum 6X HPUSaccumulation of mucus in throat, cough up mucus
Phosphorus 30X HPUScough with mucus, chest congestion
Pulsatilla 6X HPUSaccumulation of mucus, discharge of mucus, loose cough
Rumex Crispus 6X HPUSrunny nose, sneezing
Silicea 12X HPUSnasal congestion
Sulphur 12X HPUScough with thick mucus, chest congestion, nasal congestion

"HPUS" is the Homeopathic Pharmacopoeia of the United States.

Uses*

■ Helps temporarily relieve 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

Warnings

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask a doctor before use if you have

■ persistent or chronic cough such as asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if

■ symptoms persist for more than 72 hours or worsen.

■ inflammation, fever or infection is present or develops.

■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

Keep out of reach of children

Directions

■ Use as directed. ■ Do not refrigerate. ■ 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
Ask a doctor before use.
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 under 3 years
5 mL at bedtime and every 4 hours
during the night until relieved.

Drug Facts (continued)

Inactive ingredients

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

Questions?

www.hylands.com or care@hylands.com

DAYTIME HOMEOPATHIC ACTIVE INGREDIENTS 10%

NIGHTTIME HOMEOPATHIC ACTIVE INGREDIENTS 10%

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

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

Helps temporarily relieve 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.

Principal Display Panel

Hyland's

NATURALS™

•baby•

Mucus + Cold Relief*

COMBO PACK

NO SUGAR, PARABENS or DYES

DAYTIME

Mucus*

Congestion*

Runny Nose*

Sneezing*

Cough*

NIGHTTIME

Sleeplessness*

Mucus*

Congestion*

Runny Nose*

Sneezing*

Cough*

6+ MONTHS

DAYTIME - NO ALCOHOL

NIGHTTIME - LESS THAN 0.2% ALCOHOL

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

HOMEOPATHIC

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3374
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3374-11 in 1 CARTON; Type 0: Not a Combination Product11/01/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 118 mL
Part 21 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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE30 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLYCERIN (UNII: PDC6A3C0OX)  
LICORICE (UNII: 61ZBX54883)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3284-1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/13/2016
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA3 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN3 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3371-2118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/01/2018
Labeler - Hyland's Inc. (008316655)
Establishment
NameAddressID/FEIBusiness Operations
Hyland's Inc.008316655manufacture(54973-3374) , pack(54973-3374) , label(54973-3374)

Revised: 8/2023
Document Id: 0397de56-d497-5ac4-e063-6294a90accb2
Set id: 7979fc6f-6d2c-56c9-e053-2991aa0ac1f3
Version: 7
Effective Time: 20230823
 
Hyland's Inc.