Hyland's Kids Cold & Cough Nighttime Natural Grape Flavor

Hyland's Kids Cold & Cough Nighttime Natural Grape Flavor
SPL v13
SPL
SPL Set ID 7923e59a-f62c-44df-e053-2991aa0afc1e
Route
ORAL
Published
Effective Date 2023-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloride Ion (6 [hp_X]) Onion (12 [hp_X]) Matricaria Chamomilla Arabica Coffee Bean Calcium Sulfide Goldenseal Phosphorus Anemone Pulsatilla Sulfur
Inactive Ingredients
Citric Acid Monohydrate Glycyrrhiza Glabra Glycerin Water Sodium Benzoate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-11-01 Until 2021-12-15

Description

Relieves congestion, runny nose, sore throat, sneezing, cough, post nasal drip and occasional sleeplessness

Indications and Usage

Temporarily relieves symptoms of common cold in children especially at night, including: cough  runny nose  post nasal drip sneezing  nasal or chest congestion sore throat with accompanying occasional sleeplessness

Dosage and Administration

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 6 years to under 12 years Adults and children 12 years and over Children 2 years to under 6 years 5 mL at bedtime and every 4 hours during the night until relieved 10 mL at bedtime and every 4 hours during the night until relieved 15 mL at bedtime and every 4 hours during the night until relieved


Medication Information

Indications and Usage

Temporarily relieves symptoms of common cold in children especially at night, including:

cough 

runny nose 

post nasal drip

sneezing 

nasal or chest congestion

sore throat with accompanying occasional sleeplessness

Dosage and Administration

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 6 years

to under 12 years

Adults and children

12 years and over

Children 2 years

to under 6 years

5 mL at bedtime and every

4 hours during the night

until relieved

10 mL at bedtime and every

4 hours during the night

until relieved

15 mL at bedtime and every

4 hours during the night

until relieved

Description

Relieves congestion, runny nose, sore throat, sneezing, cough, post nasal drip and occasional sleeplessness

Uses

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

■ cough ■ runny nose ■ post nasal drip ■ sneezing ■ sore throat

■ nasal or chest congestion ■ occasional sleeplessness

Section 42229-5

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

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50569-3

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).

Section 51945-4

Hyland's

NATURALS™

•Kids•

Cold & Cough

NIGHTTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES*

Sleeplessness

Congestion

Runny Nose

Sore Throat

Cough

Post Nasal

Drip

2-12

YEARS

NATURAL

GRAPE FLAVOR

4 FL. OZ. (118 mL)

HOMEOPATHIC

Section 53414-9

If pregnant or breastfeeding,ask a health professional before use.

Section 55105-1

Relieves congestion, runny nose, sore throat, sneezing, cough, post nasal drip and occasional sleeplessness

Section 60561-8

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

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.

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.

Questions?

www.hylands.com or [email protected]

Active Ingredients

Allium Cepa 6X HPUS ..........watery/runny nose, cold, hacking cough, painful throat

Chamomilla 6X HPUS ......... sensitive, irritable, fussy, nocturnal occasional sleeplessness

Coffea Cruda 6X HPUS........occasional sleeplessness, restlessness

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

Inactive Ingredients

Citric Acid, Glycerine, Glycyrrhiza Extract,Natural Grape Flavor Purified Water, Sodium Benzoate.


Structured Label Content

Uses

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

■ cough ■ runny nose ■ post nasal drip ■ sneezing ■ sore throat

■ nasal or chest congestion ■ occasional sleeplessness

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 50569-3 (50569-3)

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).

Section 51945-4 (51945-4)

Hyland's

NATURALS™

•Kids•

Cold & Cough

NIGHTTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES*

Sleeplessness

Congestion

Runny Nose

Sore Throat

Cough

Post Nasal

Drip

2-12

YEARS

NATURAL

GRAPE FLAVOR

4 FL. OZ. (118 mL)

HOMEOPATHIC

Section 53414-9 (53414-9)

If pregnant or breastfeeding,ask a health professional before use.

Section 55105-1 (55105-1)

Relieves congestion, runny nose, sore throat, sneezing, cough, post nasal drip and occasional sleeplessness

Section 60561-8 (60561-8)

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

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.

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.

Questions?

www.hylands.com or [email protected]

Active Ingredients (Active ingredients)

Allium Cepa 6X HPUS ..........watery/runny nose, cold, hacking cough, painful throat

Chamomilla 6X HPUS ......... sensitive, irritable, fussy, nocturnal occasional sleeplessness

Coffea Cruda 6X HPUS........occasional sleeplessness, restlessness

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

Inactive Ingredients (Inactive ingredients)

Citric Acid, Glycerine, Glycyrrhiza Extract,Natural Grape Flavor Purified Water, Sodium Benzoate.

Indications and Usage

Temporarily relieves symptoms of common cold in children especially at night, including:

cough 

runny nose 

post nasal drip

sneezing 

nasal or chest congestion

sore throat with accompanying occasional sleeplessness

Dosage and Administration

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 6 years

to under 12 years

Adults and children

12 years and over

Children 2 years

to under 6 years

5 mL at bedtime and every

4 hours during the night

until relieved

10 mL at bedtime and every

4 hours during the night

until relieved

15 mL at bedtime and every

4 hours during the night

until relieved


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)