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

Indications and Usage

Dyatime Uses* Nighttime Uses*

Description

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


Medication Information

Active Ingredient
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.

Indications and Usage

Dyatime

Uses*

Nighttime

Uses*

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, Natural Grape Flavor, Purified Water, Sodium Benzoate.

Description

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

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

Questions?

www.hylands.com or [email protected]

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

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.

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

Active Ingredient (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.

Indications and Usage

Dyatime

Uses*

Nighttime

Uses*

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 (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

Questions?

www.hylands.com or [email protected]

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

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.

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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