Kids Cough & Mucus Nighttime Grape Flavor

Kids Cough & Mucus Nighttime Grape Flavor
SPL v10
SPL
SPL Set ID d83e7877-f599-b364-e053-2995a90ab35f
Route
ORAL
Published
Effective Date 2022-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Rumex Crispus Root (6 [hp_X]) Ipecac (12 [hp_X]) Antimony Cation (3+) (15 [hp_X]) Bryonia Alba Root Matricaria Chamomilla Whole Ferrosoferric Phosphate Calcium Sulfide Pulsatilla Vulgaris Goldenseal Phosphorus
Inactive Ingredients
Water Sodium Benzoate Glycyrrhiza Glabra Citric Acid Monohydrate Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-03-01

Description

Temporarily relieves symptoms of common cold in children at night, including cough, runny nose, sneezing, sore throat, chest or nasal congestion, mucus in chest or throat, occasional sleeplessness


Medication Information

Description

Temporarily relieves symptoms of common cold in children at night, including cough, runny nose, sneezing, sore throat, chest or nasal congestion, mucus in chest or throat, occasional sleeplessness

Uses

Temporarily relieves symptoms of common cold in children at night, including: ■ cough ■ runny nose ■ sneezing ■ sore throat

■ chest or nasal congestion ■ mucus in chest or throat ■ occasional sleeplessness

Section 55105-1

Temporarily relieves symptoms of common cold in children at night, including cough, runny nose, sneezing, sore throat, chest or nasal congestion, mucus in chest or throat, occasional sleeplessness

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 Purpose
Antimonium Tartaricum 15X HPUS cough
Bryonia Alba 15X HPUS sore throat, mucus in throat, cough
Chamomilla 6X HPUS occasional sleeplessness
Ferrum Phosphoricum 12X HPUS mucus in throat, cough
Hepar Sulph Calc 12X HPUS mucus in chest, cough
Hydrastis Canadensis 15X HPUS occasional sleeplessness

due to mucus in throat
Ipecacuanha 12X HPUS cough, sore throat
Phosphorus 15X HPUS runny nose, chest or nasal congestion
Pulsatilla 12X HPUS mucus in chest or throat, cough, sneezing
Rumex Crispus 6X HPUS runny nose, sneezing

"HPUS" is the Homeopathic Pharmacopoeia of the United States.

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•

Cough &

Mucus*

NIGHTTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES

Sleeplessness

Cough

Mucus

Congestion

Runny Nose

EFFECTIVE

MUCUS

RELIEF

2-12

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

Temporarily relieves symptoms of common cold in children at night, including: ■ cough ■ runny nose ■ sneezing ■ sore throat

■ chest or nasal congestion ■ mucus in chest or throat ■ occasional sleeplessness

Section 55105-1 (55105-1)

Temporarily relieves symptoms of common cold in children at night, including cough, runny nose, sneezing, sore throat, chest or nasal congestion, mucus in chest or throat, occasional sleeplessness

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)
Active ingredients Purpose
Antimonium Tartaricum 15X HPUS cough
Bryonia Alba 15X HPUS sore throat, mucus in throat, cough
Chamomilla 6X HPUS occasional sleeplessness
Ferrum Phosphoricum 12X HPUS mucus in throat, cough
Hepar Sulph Calc 12X HPUS mucus in chest, cough
Hydrastis Canadensis 15X HPUS occasional sleeplessness

due to mucus in throat
Ipecacuanha 12X HPUS cough, sore throat
Phosphorus 15X HPUS runny nose, chest or nasal congestion
Pulsatilla 12X HPUS mucus in chest or throat, cough, sneezing
Rumex Crispus 6X HPUS runny nose, sneezing

"HPUS" is the Homeopathic Pharmacopoeia of the United States.

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•

Cough &

Mucus*

NIGHTTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES

Sleeplessness

Cough

Mucus

Congestion

Runny Nose

EFFECTIVE

MUCUS

RELIEF

2-12

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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