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

Kids Cough and Mucus Nighttime Grape by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

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, coug
• 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 4 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.

Principal Display Panel

Hyland's

NATURALS™

Kids

Cough &

Mucus*

NIGHTTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES

Sleeplessness

Cough

Mucus

Congestion

Runny Nose

EFFECTIVE

MUCUS

RELIEF

4 - 12

YEARS

NATURAL

GRAPE FLAVOR

4 FL. OZ. (118 mL)

HOMEOPATHIC

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-4114
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C)	RUMEX CRISPUS ROOT	6 [hp_X]  in 1 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	12 [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
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5)	ANTIMONY POTASSIUM TARTRATE	15 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	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
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	6 [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

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

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE (Natural Grape Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-4114-1	1 in 1 BOTTLE, PLASTIC	12/01/2022
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		12/01/2022

Labeler - Hyland's Consumer Health Inc. (008316655)

Establishment
Name	Address	ID/FEI	Business Operations
Hyland's INC		008316655	label(54973-4114) , pack(54973-4114) , manufacture(54973-4114)