Kids Cough & Mucus Daytime Nighttime Combo Pack Cherry Berry

Drug Details [pdf]

KIDS COUGH AND MUCUS DAYTIME NIGHTTIME CHERRY BERRY- antimony potassium tartrate, rumex crispus root, anemone pulsatilla, phosphorus, goldenseal, ferrosoferric phosphate, calcium sulfide, bryonia alba root, ipecac, matricaria recutita
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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Kids Cough & Mucus Daytime Nighttime Combo Pack Cherry Berry

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

DAYTIME

Drug Facts

Active ingredients	Purpose
Antimonium Tartaricum 15X HPUS	cough
Bryonia Alba 15X HPUS	sore throat, mucus in throat, cough
Ferrum Phosphoricum 12X HPUS	mucus in throat, cough
Hepar Sulph Calc 12X HPUS	mucus in chest, cough
Ipecacuanha 12X HPUS	cough, sore throat
Phosphorus 15X HPUS	runny nose, chest or nasal congestion
Pulsatilla 12X HPUS	mucus in chest or throat, cough, sneezing
Rumex Crispus 6X HPUS	runny nose, sneezing

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

Uses

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

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 smoking, 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 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

If pregnant or breastfeeding

Ask a health professional before use.

Keep out of reach of children

Directions

■ Use as directed. ■ Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing cup provided. ■ Do not use dosing cup with other products. ■ On dosing cup, mL = milliliter.

Children 2 years to under 6 years	5 mL up to 6 times per day (every 4 hours).
Children 6 years to under 12 years	10 mL up to 6 times per day (every 4 hours).
Adults and children 12 years and over	15 mL up to 6 times per day (every 4 hours).

Inactive ingredients

Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Cherry Flavor, Natural Strawberry Flavor, Purified Water, Sodium Benzoate.

NIGHTTIME

Drug Facts

Active ingredients	Purpose
Antimonium Tartaricum 15X HPUS	cough
Bryonia Alba 15X HPUS	sore throat, mucus in throat, cough
Chamomilla 6X HPUS	occasional sleeplessness
Ferrum Phosphoricum 12X HPUS	mucus in throat, cough
Hepar Sulph Calc 12X HPUS	mucus in chest, cough
Hydrastis Canadensis 15X HPUS	occasional sleeplessness due to mucus in throat
Ipecacuanha 12X HPUS	cough, sore throat
Phosphorus 15X HPUS	runny nose, chest or nasal congestion
Pulsatilla 12X HPUS	mucus in chest or throat, cough, sneezing
Rumex Crispus 6X HPUS	runny nose, sneezing

HPUS" is the Homeopathic Pharmacopoeia of the United States.

Uses

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

Stop use and ask a doctor if

■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

If pregnant or breastfeeding

Ask a health professional before use.

Keep out of reach of children.

Directions

Children 2 years to under 6 years	5 mL at bedtime and every 4 hours during the night until relieved.
Children 6 years to under 12 years	10 mL at bedtime and every 4 hours during the night until relieved.
Adults and children 12 years and over	15 mL at bedtime and every 4 hours during the night until relieved.

Inactive ingredients

Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Cherry Flavor, Natural Strawberry Flavor, Purified Water, Sodium Benzoate.

Questions?

www.hylands.com or (800) 624-9659

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

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

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

Hyland's

NATURALS™

Kids

NEW

Cough & Mucus*

COMBO PACK

NO ALCOHOL, SUGAR,

PARABENS or DYES

DAYTIME

Cough

Mucus

Congestion

Runny Nose

NIGHTTIME

Sleeplessness

Cough

Mucus

Congestion

Runny Nose

2-12- YEARS

EFFECTIVE

MUCUS

RELIEF

NATURAL CHERRY

BERRY FLAVOR

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

HOMEOPATHIC

Carton

KIDS COUGH AND MUCUS DAYTIME NIGHTTIME CHERRY BERRY
antimony potassium tartrate, rumex crispus root, anemone pulsatilla, phosphorus, goldenseal, ferrosoferric phosphate, calcium sulfide, bryonia alba root, ipecac, matricaria recutita kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-4064

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 54973-4064-1	1 in 1 CARTON; Type 0: Not a Combination Product	03/01/2022

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

KIDS COUGH AND MUCUS CHERRY BERRY
antimony potassium tartrate, calcium sulfide, ipecac, ferrosoferric phosphate, phosphorus, rumex crispus root, bryonia alba root, pulsatilla vulgaris liquid

Product Information
Item Code (Source)	NDC: 54973-4061
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5)	ANTIMONY POTASSIUM TARTRATE	15 [hp_X] in 1 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	12 [hp_X] in 1 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	12 [hp_X] in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	15 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	15 [hp_X] in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	12 [hp_X] in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	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
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LICORICE (UNII: 61ZBX54883)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (Cherry Berry)	Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC: 54973-4061-1	1 in 1 CARTON
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		03/01/2022

Part 2 of 2

KIDS COUGH AND MUCUS NIGHTTIME CHERRY BERRY
antimony potassium tartrate, rumex crispus root, anemone pulsatilla, phosphorus, goldenseal, ferrosoferric phosphate, calcium sulfide, bryonia alba root, ipecac, matricaria recutita liquid

Product Information
Item Code (Source)	NDC: 54973-4063
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	15 [hp_X] in 1 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	12 [hp_X] in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X] in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	6 [hp_X] in 1 mL
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5)	ANTIMONY POTASSIUM TARTRATE	15 [hp_X] in 1 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	12 [hp_X] in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	15 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	15 [hp_X] in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (Cherry Berry)	Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC: 54973-4063-1	1 in 1 CARTON
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		03/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/01/2022	06/21/2022

Labeler - Hyland’s (028570695)

Name	Address	ID/FEI	Business Operations
Establishment
Standard Homeopathic Company		008316655	manufacture(54973-4064) , pack(54973-4064) , label(54973-4064)

Name	Address	ID/FEI	Business Operations
Establishment
Standard Homeopathic Company		080253323	pack(54973-4064) , label(54973-4064) , manufacture(54973-4064)

Name	Address	ID/FEI	Business Operations
Establishment
LGM Pharma Solutions, LLC		117549198	manufacture(54973-4064) , pack(54973-4064) , label(54973-4064)

Revised: 6/2022

Document Id: e1fbe5b7-0eff-aed3-e053-2995a90a29e0

Set id: d9307c81-0624-8569-e053-2995a90ade1b

Version: 2

Effective Time: 20220621

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Kids Cough & Mucus Daytime Nighttime Combo Pack Cherry Berry

Kids Cough and Mucus Daytime Nighttime Cherry Berry by

Drug Labeling and Warnings

Drug Details [pdf]

Kids Cough & Mucus Daytime Nighttime Combo Pack Cherry Berry

DAYTIME

Drug Facts

Uses

Warnings

Sore throat warning

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breastfeeding

Keep out of reach of children

Directions

Inactive ingredients

NIGHTTIME

Drug Facts

Uses

Warnings

Sore throat warning

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breastfeeding

Keep out of reach of children.

Directions

Inactive ingredients

Questions?

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

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

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

Kids Cough & Mucus Daytime Nighttime Combo Pack Cherry Berry

Kids Cough and Mucus Daytime Nighttime Cherry Berry by

Drug Labeling and Warnings

Drug Details [pdf]

Kids Cough & Mucus Daytime Nighttime Combo Pack Cherry Berry

DAYTIME

Drug Facts

Uses

Warnings

Sore throat warning

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breastfeeding

Keep out of reach of children

Directions

Inactive ingredients

NIGHTTIME

Drug Facts

Uses

Warnings

Sore throat warning

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breastfeeding

Keep out of reach of children.

Directions

Inactive ingredients

Questions?

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

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

Package Label - ​TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night) Carton

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