Hyland's Naturals Kids Cold & Cough Nighttime Natural Grape Flavor

Hyland's Naturals Kids Cold & Cough Nighttime Natural Grape Flavor
SPL v1
SPL
SPL Set ID e676dbb7-212f-47e3-e053-2995a90af4e1
Route
ORAL
Published
Effective Date 2022-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-12-01

Description

Temporarily relieves cough, runny nose, post nasal drip, sneezing, sore throat, nasal or chest congestion, occasional sleeplessness


Medication Information

Description

Temporarily relieves cough, runny nose, post nasal drip, sneezing, sore throat, nasal or chest congestion, 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 55105-1

Temporarily relieves cough, runny nose, post nasal drip, sneezing, sore throat, nasal or chest congestion, occasional sleeplessness

Section 55106-9
Active ingredients Purpose
Allium Cepa 6X HPUS ......................................................... watery/runny nose, cold, hacking cough, painful throat
Chamomilla 6X HPUS........................................................... occasional sleeplessness
Coffea Cruda 6X HPUS......................................................... occasional sleeplessness
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.

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.

Questions?

www.hylands.com or [email protected]

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.

Inactive Ingredients

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

Principal Display Panel

Hyland's

NATURALS™

•Kids•

Cold &

Cough*

NIGHTTIME

NO ALCOHOL, SUGAR,

PARABENS, or DYES

Sleeplessness

Congestion

Runny Nose

Sore Throat

Cough

Post Nasal

Drip

4 - 12

YEARS

NATURAL

GRAPE FLAVOR

4 FL. OZ. (118 mL)

HOMEOPATHIC

If Pregnant Or Breastfeeding

Ask a health professional before use.

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.

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).


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 55105-1 (55105-1)

Temporarily relieves cough, runny nose, post nasal drip, sneezing, sore throat, nasal or chest congestion, occasional sleeplessness

Section 55106-9 (55106-9)
Active ingredients Purpose
Allium Cepa 6X HPUS ......................................................... watery/runny nose, cold, hacking cough, painful throat
Chamomilla 6X HPUS........................................................... occasional sleeplessness
Coffea Cruda 6X HPUS......................................................... occasional sleeplessness
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.

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.

Questions?

www.hylands.com or [email protected]

Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

Hyland's

NATURALS™

•Kids•

Cold &

Cough*

NIGHTTIME

NO ALCOHOL, SUGAR,

PARABENS, or DYES

Sleeplessness

Congestion

Runny Nose

Sore Throat

Cough

Post Nasal

Drip

4 - 12

YEARS

NATURAL

GRAPE FLAVOR

4 FL. OZ. (118 mL)

HOMEOPATHIC

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

Ask a health professional before use.

Stop Use and Ask A Doctor If (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.

Ask A Doctor Before Use If You Have (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).


Advanced Ingredient Data


Raw Label Data

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