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

Kids Cough and Mucus Daytime Grape Flavor by

Drug Labeling and Warnings

Kids Cough and Mucus Daytime Grape Flavor 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

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

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

■ 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 4 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.

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

DAYTIME

NO, ALCOHOL, SUGAR,

PARABENS or DYES

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 DAYTIME GRAPE FLAVOR 
bryonia alba root,calcium sulfide,pulsatilla vulgaris whole,ferrosoferric phosphate,phosphorus,antimony potassium tartrate,ipecac,rumex crispus root liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-4113
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	15 [hp_X]  in 1 mL
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5)	ANTIMONY POTASSIUM TARTRATE	15 [hp_X]  in 1 mL
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
PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (PULSATILLA VULGARIS WHOLE - UNII:I76KB35JEV)	PULSATILLA VULGARIS WHOLE	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

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
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: 54973-4113-1	1 in 1 CARTON	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	manufacture(54973-4113) , label(54973-4113) , pack(54973-4113)