KIDS COLD AND COUGH DAYTIME- calcium sulfide,goldenseal,onion,phosphorus,pulsatilla vulgaris, sodium chloride liquid

Kids Cold and Cough Daytime by

Drug Labeling and Warnings

Kids Cold and Cough Daytime 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

Runny Nose, Sore Throat, Sneezing, Cough, Post Nasal Drip, Aasal or Chest Congestion

Drug Facts

• Active ingredients: Purpose*
• Allium Cepa 6X HPUS...........................................: watery/runny nose, cold, hacking cough, painful throat
• Hepar Sulph Calc 12X HPUS..............................................: cold, sneezing
• Hydrastis 6X HPUS................................................: rattling/tickling cough, sinus congestion, dry/raw/sore throat
• Natrum Muriaticum 6X HPUS...............................: dry cough, sore throat
• Phosphorus 12X HPUS..................................................: hoarse/dry cough, nasal congestion, chest congestion
• Pulsatilla 6X HPUS .............................: moist cough, cold, post nasal drip
• Sulphur 12X HPUS.........................: chest congestion, nasal congestion, sneezing, runny nose

"HPUS" is the Homeopathic Pharmacopoeia of the United States.

Uses*

■ Helps temporarily relieve symptoms of common cold in children, including:

■ runny nose ■ sore throat ■ sneezing ■ cough
■ post nasal drip ■ nasal or chest congestion

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, 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

Cold &

Cough*

DAYTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES

Congestion*

Runny Nose*

Sore Throat*

Cough*

Post Nasal

Drip*

4 - 12

YEARS

4 FL. OZ. (118 mL)

HOMEOPATHIC

INGREDIENTS AND APPEARANCE

KIDS COLD AND COUGH DAYTIME 
calcium sulfide,goldenseal,onion,phosphorus,pulsatilla vulgaris, sodium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-4109
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS WHOLE - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	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)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-4109-1	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(54973-4109) , pack(54973-4109) , label(54973-4109)