Kids Cough & Mucus Combo Pack Daytime Nighttime Grape Flavor

Kids Cough & Mucus Combo Pack Daytime Nighttime Grape Flavor
SPL v10
SPL
SPL Set ID d92ab90b-b960-3df2-e053-2a95a90ace89
Route
ORAL
Published
Effective Date 2023-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-03-01

Description

Active ingredients Purpose Antimonium Tartaricum 15X HPUS cough Bryonia Alba 15X HPUS sore throat, mucus in throat, cough Ferrum Phosphoricum 12X HPUS mucus in throat, cough Hepar Sulph Calc 12X HPUS mucus in chest, cough 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.


Medication Information

Description

Active ingredients Purpose Antimonium Tartaricum 15X HPUS cough Bryonia Alba 15X HPUS sore throat, mucus in throat, cough Ferrum Phosphoricum 12X HPUS mucus in throat, cough Hepar Sulph Calc 12X HPUS mucus in chest, cough 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.

Uses

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

■ cough ■ runny nose ■ sneezing ■ sore throat

■ chest or nasal congestion ■ mucus in chest or throat

Section 55105-1

Helps temporarily relieve 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 55106-9
Active ingredients Purpose
Antimonium Tartaricum 15X HPUS cough
Bryonia Alba 15X HPUS sore throat, mucus in throat, cough
Ferrum Phosphoricum 12X HPUS mucus in throat, cough
Hepar Sulph Calc 12X HPUS mucus in chest, cough
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.

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 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™

•Kids•

Cough & Mucus*

COMBO PACK

NO ALCOHOL, SUGAR, PARABENS or DYES

DAYTIME

Cough

Mucus

Runny Nose

NIGHTTIME

Sleeplessness

Cough

Mucus

Congestion

Runny Nose

2 - 12 YEARS

EFFECTIVE

MUCUS

RELIEF

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:

■ cough ■ runny nose ■ sneezing ■ sore throat

■ chest or nasal congestion ■ mucus in chest or throat

Section 55105-1 (55105-1)

Helps temporarily relieve 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 55106-9 (55106-9)
Active ingredients Purpose
Antimonium Tartaricum 15X HPUS cough
Bryonia Alba 15X HPUS sore throat, mucus in throat, cough
Ferrum Phosphoricum 12X HPUS mucus in throat, cough
Hepar Sulph Calc 12X HPUS mucus in chest, cough
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.

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 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.

Principal Display Panel

Hyland's

NATURALS™

•Kids•

Cough & Mucus*

COMBO PACK

NO ALCOHOL, SUGAR, PARABENS or DYES

DAYTIME

Cough

Mucus

Runny Nose

NIGHTTIME

Sleeplessness

Cough

Mucus

Congestion

Runny Nose

2 - 12 YEARS

EFFECTIVE

MUCUS

RELIEF

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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