COLD AND COUGH 4 KIDS- onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid
HYLAND'S, 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.

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Hyland's 4 Kids Daytime Cold & Cough

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" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

■ Temporarily relieves symptoms of common cold

in children, including:

■ runny nose ■ sore throat ■ sneezing

■ cough ■ post nasal drip

■ nasal or chest congestion

Warnings

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Consult a physician if:

■ Symptoms persist for more than 7 days or worsen

■ Inflammation, fever or infection develops

■ Symptoms are accompanied by high fever (101°F)

■ Cough tends to recur or is accompanied by high fever, rash or persistent headache

Keep this and all medications out of the reach of children.

Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed medical professional.

A persistent cough may be a sign of a serious condition.

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly.

In case of emergency, contact a medical professional or Poison Control Center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Drug Facts (continued)

Directions

■ 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 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).

Other information

■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

■ The inner packaged bottle is child-resistant.

■ Store at room temperature.

■ Do not refrigerate.

Inactive ingredients

Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

Questions or comments?

(800) 624-9659

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

HOMEOPATHIC

NDC 54973-3075-1

2-12

YEARS

NEW

LOOK

4 kids

SINCE 1903
Hyland's

DAYTIME

Cold &
Cough*

Relieves congestion,

runny nose, sore

throat, sneezing, cough

and post nasal drip

NO ALCOHOL or PARABENS

NO SUGAR or DYES

Natural
Relief

4 FL. OZ. (118 mL)

*SEE NOTE ON SIDE PANEL BELOW DRUG FACTS

carton

COLD AND COUGH 4 KIDS
onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54973-3075
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [hp_X] in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	6 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X] in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	6 [hp_X] in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54973-3075-1	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2008
2	NDC:54973-3075-2	1 in 1 CARTON	08/01/2008
2		19.8 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		08/01/2008

Labeler - HYLAND'S, INC. (028570695)

Name	Address	ID/FEI	Business Operations
Establishment
Standard Homeopathic Company		008316655	manufacture(54973-3075)

Name	Address	ID/FEI	Business Operations
Establishment
Standard Homeopathic Company		080253323	manufacture(54973-3075) , label(54973-3075) , pack(54973-3075)

Name	Address	ID/FEI	Business Operations
Establishment
LGM Pharma Solutions, LLC		117549198	manufacture(54973-3075) , pack(54973-3075) , label(54973-3075)

Name	Address	ID/FEI	Business Operations
Establishment
Lifetech Resources		622559110	manufacture(54973-3075) , pack(54973-3075) , label(54973-3075)

Name	Address	ID/FEI	Business Operations
Establishment
Applied Laboratories, Inc.		876754375	manufacture(54973-3075) , pack(54973-3075)

Revised: 7/2021

Document Id: c68fddca-05be-40c6-e053-2995a90af5b0

Set id: e06599ca-fc94-4b2c-829e-f3d4ec866ed6

Version: 6

Effective Time: 20210707

HYLAND'S, INC.