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

Relieves congestion, runny nose, cough and loosens mucus

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.

Children under 6 months of age	Consult a physician.
Children 6 months to under 1 year	2.5 mL up to 4 times per day (every 6 hours).
Children 1 to 3 years	5 mL up to 6 times per day (every 4 hours).

Drug Facts (continued)

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.

Questions or comments?

(800) 624-9659

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

HOMEOPATHIC

NDC 54973-3284-1

MONTHS

NEW

LOOK

BABY

SINCE 1903

Hyland's

DAYTIME

Mucus +

Cold Relief *

Relieves congestion, runny nose,

cough and loosens mucus

NO ALCOHOL or PARABENS

NO SUGAR or DYES

NATURAL

RELIEF

4 FL. OZ. (118 mL)

*SEE NOTE ON SIDE

PANEL BELOW DRUG FACTS

carton

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
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54973-3284
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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
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
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C)	RUMEX CRISPUS ROOT	6 [hp_X] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54973-3284-1	1 in 1 CARTON	05/13/2016
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:54973-3284-2	2.5 mL in 1 POUCH; Type 0: Not a Combination Product	12/23/2016
3	NDC:54973-3284-3	1 in 1 CARTON	08/01/2018
3		148 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

Labeler - Hyland's (028570695)

Name	Address	ID/FEI	Business Operations
Establishment
Standard Homeopathic Company		008316655	manufacture(54973-3284) , pack(54973-3284)

Name	Address	ID/FEI	Business Operations
Establishment
Applied Laboratories, Inc.		117337220	manufacture(54973-3284) , pack(54973-3284) , label(54973-3284)

Name	Address	ID/FEI	Business Operations
Establishment
LGM Pharma Solutions, LLC		117549198	manufacture(54973-3284) , pack(54973-3284) , label(54973-3284)

Revised: 7/2021

Document Id: c69d8127-78a0-3424-e053-2995a90a0bc6

Set id: d934cc8a-1e43-4942-858a-05b5d068679a

Version: 7

Effective Time: 20210708

Hyland's