Hyland's Naturals Kids Cough & Mucus Nighttime Cherry Berry Flavor

Kids Cough and Mucus Nighttime Cherry Berry by

Drug Labeling and Warnings

Kids Cough and Mucus Nighttime Cherry Berry by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's, Standard Homeopathic Company, LGM Pharma Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 
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 Naturals Kids Cough & Mucus Nighttime Cherry Berry Flavor

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

Drug Facts

Active ingredients

• 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

■ 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 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 - 118 mL Bottle Carton

Hyland's

Naturals™

Kids

New

Cough &

Mucus

NIGHTTIME*

NO ALCOHOL, SUGAR,

PARABENS or DYES

Sleeplessness

Cough

Mucus

Congestion

Runny Nose

EFFECTIVE

MUCUS

RELIEF

2-12

YEARS

NATURAL CHERRY

BERRY FLAVOR

4 FL. OZ. (118 mL)

HOMEOPATHIC

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
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-4063
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5)	ANTIMONY POTASSIUM TARTRATE	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
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	15 [hp_X]  in 1 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	12 [hp_X]  in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	6 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	15 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-4063-1	1 in 1 CARTON	03/01/2022
1		118 mL in 1 BOTTLE, PLASTIC; 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	06/21/2022

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-4063) , pack(54973-4063) , label(54973-4063)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		080253323	manufacture(54973-4063) , pack(54973-4063) , label(54973-4063)

Establishment
Name	Address	ID/FEI	Business Operations
LGM Pharma Solutions, LLC		117549198	manufacture(54973-4063) , label(54973-4063) , pack(54973-4063)

Revised: 6/2022

Document Id: e1faad89-8db7-86a3-e053-2a95a90a7d32

34390-5

Set id: d8ca1d1f-f947-480b-e053-2a95a90a096e

Version: 2

Effective Time: 20220621