BABY MUCUS COLD RELIEF DAY AND NIGHT VALUE PACK- bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, silicon dioxide, onion, matricaria recutita, arabica coffee bean, goldenseal, strychnos nux-vomica seed, and sulfur
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 Baby Mucus Cold Relief Day and Night Value Pack

DAYTIME

Drug Facts

Active ingredients	Purpose
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
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 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. 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 preprinted tamper band is broken or missing.

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 teaspoon up to 4 times daily (every 6 hours)
Children 1 to 3 years of age	5 mL or 1 teaspoon up to 6 times daily (every 4 hours)

Inactive ingredients

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

NIGHTTIME

Drug Facts

Active ingredients	Purpose
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
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
Nux Vomica 6X HPUS	tired, difficulty falling asleep, (0.0000016% Alkaloids, calculated) frequent waking
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 symptoms of colds, including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing, nasal congestion; and irritability, fussiness and occasional sleeplessness.

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, unless directed by a licensed health care professional.

Do not use if preprinted tamper band is broken or missing.

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 teaspoon up to 4 times daily (every 6 hours)
Children 1 to 3 years of age	5 mL or 1 teaspoon up to 6 times daily (every 4 hours)

Inactive ingredients

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

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - Kit Carton

New!

NDC 54973-3313-1
HOMEOPATHIC

Ages 6 months+

SINCE 1903
Hyland's®
Baby

Natural
Relief

Day & Night Value Pack

Daytime

Mucus +
Cold Relief

LOOSENS MUCUS,
RELIEF OF
CONGESTION,
RUNNY NOSE
AND COUGH*

ALCOHOL FREE

4 FL. OZ. (118 mL) Daytime

Nighttime

Mucus +
Cold Relief

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

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54973-3313

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54973-3313-1	1 in 1 CARTON	03/30/2017

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 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
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
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

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	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 COLD RELIEF
onion, bryonia alba root, matricaria recutita, arabica coffee bean, euphrasia stricta, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, rumex crispus root, silicon dioxide, and sulfur liquid

Product Information
Item Code (Source)	NDC:54973-3251
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	3 [hp_X] in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	3 [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
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	6 [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
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54973-3251-1	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		12/28/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/30/2017	11/29/2022

Labeler - Hyland's Inc. (008316655)

Name	Address	ID/FEI	Business Operations
Establishment
Hyland's Inc.		008316655	manufacture(54973-3313, 54973-3284, 54973-3251) , pack(54973-3313, 54973-3284, 54973-3251) , label(54973-3313, 54973-3284, 54973-3251)

Name	Address	ID/FEI	Business Operations
Establishment
Applied Laboratories, Inc.		117337220	pack(54973-3313, 54973-3284, 54973-3251)

Name	Address	ID/FEI	Business Operations
Establishment
LGM Pharma Solutions, LLC		117549198	manufacture(54973-3313) , pack(54973-3313) , label(54973-3313)

Revised: 11/2022

Document Id: eea18052-6aa1-d9cb-e053-2a95a90a047b

Set id: 45eb3326-1310-4044-997c-42c4abc6789d

Version: 3

Effective Time: 20221129

Hyland's Inc.