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 
Hyland's Consumer Health Inc.

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.

----------

Hyland's Naturals Kids Cough & Mucus Nighttime Grape Flavor

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 ingredientsPurpose
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

Carton

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4114
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 1 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE12 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL15 [hp_X]  in 1 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC12 [hp_X]  in 1 mL
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE15 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS15 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT15 [hp_X]  in 1 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE6 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS12 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Natural Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-4114-11 in 1 BOTTLE, PLASTIC12/01/2022
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/01/2022
Labeler - Hyland's Consumer Health Inc. (008316655)
Establishment
NameAddressID/FEIBusiness Operations
Hyland's INC008316655label(54973-4114) , pack(54973-4114) , manufacture(54973-4114)

Revised: 4/2024
Document Id: 16c7c964-18cd-2bc5-e063-6394a90aa45b
Set id: e76509f9-6219-908e-e053-2a95a90a21b3
Version: 3
Effective Time: 20240423
 
Hyland's Consumer Health Inc.