Hyland's Naturals Kids Cold & Cough Combo Pack Grape Flavor

Hyland's Naturals Kids Cold & Cough Combo Pack Grape Flavor
SPL v3
SPL
SPL Set ID e6ffd6d1-fcfb-547d-e053-2995a90af9b6
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 Sulfur Arabica Coffee Bean Pulsatilla Vulgaris Top Phosphorus Onion Pulsatilla Vulgaris Whole
Inactive Ingredients
Glycerin Water Citric Acid Monohydrate Sodium Benzoate Glycyrrhiza Glabra

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-12-01

Description

Sleeplessness, Congestion, Runny Nose, Sore Throat, Cough, Post Nasal Drip

Indications and Usage

Dyatime Uses* Nighttime Uses*


Medication Information

Indications and Usage

Dyatime

Uses*

Nighttime

Uses*

Description

Sleeplessness, Congestion, Runny Nose, Sore Throat, Cough, Post Nasal Drip

Uses*

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

■ runny nose ■ sore throat ■ sneezing ■ cough

■ post nasal drip ■ nasal or chest congestion

Section 55105-1

Sleeplessness, Congestion, Runny Nose, Sore Throat, Cough, Post Nasal Drip

Section 55106-9
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.

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).

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™

Cold & Cough*

COMBO PACK

NO ALCOHOL, SUGAR, PARABENS or DYES

DAYTIME NIGHTTIME
Congestion*

Sleeplessness*

Runny Nose* Congestion*
Sore Throat* Runny Nose*
Cough* Sore Throat*
Post Nasal Drip* Cough*
Post Nasal Drip*

4 - 12 YEARS

NATURAL

GRAPE FLAVOR

TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)

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, including:

■ runny nose ■ sore throat ■ sneezing ■ cough

■ post nasal drip ■ nasal or chest congestion

Section 55105-1 (55105-1)

Sleeplessness, Congestion, Runny Nose, Sore Throat, Cough, Post Nasal Drip

Section 55106-9 (55106-9)
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.

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).

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.

Indications and Usage

Dyatime

Uses*

Nighttime

Uses*

Principal Display Panel

Hyland's

NATURALS™

Cold & Cough*

COMBO PACK

NO ALCOHOL, SUGAR, PARABENS or DYES

DAYTIME NIGHTTIME
Congestion*

Sleeplessness*

Runny Nose* Congestion*
Sore Throat* Runny Nose*
Cough* Sore Throat*
Post Nasal Drip* Cough*
Post Nasal Drip*

4 - 12 YEARS

NATURAL

GRAPE FLAVOR

TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)

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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