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

Drug Details [pdf]

PURPOSE

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*

■ 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.
Principal Display Panel - 4 FL. OZ. (118 mL) Carton

Hyland's

NATURALS™

Kids

Cough &

Mucus*

NIGHTTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES

Sleeplessness*

Cough*

Mucus*

Congestion*

Runny Nose*

EFFECTIVE

MUCUS

RELIEF

2-12

YEARS

NATURAL

GRAPE FLAVOR

4 FL. OZ. (118 mL)

HOMEOPATHIC
Principal Display Panel - 5 FL. OZ (148 mL) Carton

54973-4057-2 5 FL. OZ. (148 mL)

INGREDIENTS AND APPEARANCE

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
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-4057
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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
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
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA WHOLE - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA WHOLE	6 [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
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	12 [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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 54973-4057-1	1 in 1 CARTON	03/01/2022
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-4057-2	1 in 1 CARTON	03/01/2022
2		148 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

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

Name	Address	ID/FEI	Business Operations
Establishment
Hyland's Consumer Health Inc.		008316655	manufacture(54973-4057) , pack(54973-4057) , label(54973-4057)