KIDS COUGH AND MUCUS DAY AND NIGHT GRAPE- rumex crispus root, antimony potassium tartrate, bryonia alba root, matricaria chamomilla whole, pulsatilla vulgaris, calcium sulfide, ipecac, goldenseal, phosphorus, ferrosoferric phosphate kit

Kids Cough and Mucus Day and Night Grape by

Drug Labeling and Warnings

Kids Cough and Mucus Day and Night Grape by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DAYTIME

ACTIVE INGREDIENT

• 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

■ Helps temporarily relieve 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 Grape Flavor, Purified Water, Sodium Benzoate.

NIGHTTIME

Drug Facts

ACTIVE INGREDIENT

• 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

■ Helps temporarily relieve 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

■ 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 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 Grape Flavor, Purified Water, Sodium Benzoate.

Questions?

www.hylands.com or care@hylands.com

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

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

PURPOSE

Helps temporarily relieve 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.

Principal Display Panel

Hyland's

NATURALS™

Kids

Cough & Mucus*

COMBO PACK

NO ALCOHOL, SUGAR, PARABENS or DYES

DAYTIME

Cough

Mucus

Runny Nose

NIGHTTIME

Sleeplessness

Cough

Mucus

Congestion

Runny Nose

2 - 12 YEARS

EFFECTIVE

MUCUS

RELIEF

NATURAL

GRAPE FLAVOR

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

HOMEOPATHIC

INGREDIENTS AND APPEARANCE

KIDS COUGH AND MUCUS DAY AND NIGHT GRAPE 
rumex crispus root, antimony potassium tartrate, bryonia alba root, matricaria chamomilla whole, pulsatilla vulgaris, calcium sulfide, ipecac, goldenseal, phosphorus, ferrosoferric phosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-4059

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-4059-1	1 in 1 CARTON; Type 0: Not a Combination Product	03/01/2022

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	118 mL
Part 2	1 BOTTLE, PLASTIC	118 mL

Part 1 of 2

KIDS COUGH AND MUCUS NIGHTTIME GRAPE FLAVOR 
rumex crispus root, antimony potassium tartrate, bryonia alba root, matricaria chamomilla whole, pulsatilla vulgaris, calcium sulfide, ipecac, goldenseal, phosphorus, ferrosoferric phosphate liquid

Product Information
Item Code (Source)	NDC: 54973-4057
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA WHOLE - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA WHOLE	6 [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
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	15 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	15 [hp_X]  in 1 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	12 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	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
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	12 [hp_X]  in 1 mL
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5)	ANTIMONY POTASSIUM TARTRATE	15 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-4057-1	1 in 1 CARTON
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-4057-2	5 mL in 1 POUCH; Type 0: Not a Combination Product

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

Part 2 of 2

COUGH AND MUCUS GRAPE FLAVOR 
antimony potassium tartrate,bryonia alba root,ferrosoferric phosphate,calcium sulfide,ipecac,phosphorus,anemone pulsatilla,rumex crispus root liquid

Product Information
Item Code (Source)	NDC: 54973-4056
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	12 [hp_X]  in 1 mL
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
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5)	ANTIMONY POTASSIUM TARTRATE	15 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	15 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-4056-1	1 in 1 CARTON
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-4056-2	5 mL in 1 POUCH; Type 0: Not a Combination Product

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

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

Labeler - Hyland's Inc. (008316655)

Establishment
Name	Address	ID/FEI	Business Operations
Hyland's Inc.		008316655	manufacture(54973-4059) , pack(54973-4059) , label(54973-4059)