Hyland's Naturals Baby Mucus + Cold Relief Nighttime

Hyland's Naturals Baby Mucus + Cold Relief Nighttime
SPL v7
SPL
SPL Set ID 736b2487-e81d-d172-e053-2a91aa0ab0cf
Route
ORAL
Published
Effective Date 2023-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Sulfide (12 [hp_X]) Phosphorus (30 [hp_X]) Anemone Pulsatilla (6 [hp_X]) Silicon Dioxide (3 [hp_X]) Goldenseal Onion Bryonia Alba Root Euphrasia Stricta Matricaria Chamomilla Arabica Coffee Bean Chloride Ion Rumex Crispus Root Sulfur
Inactive Ingredients
Water Glycyrrhiza Glabra Citric Acid Monohydrate Glycerin Sodium Benzoate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2018-11-01 Until 2021-12-27

Description

Relieves mucus, congestion, runny nose, sneezing, cough and occasional sleeplessness

Indications and Usage

Added bullet

Purpose

Relieves mucus, congestion, runny nose, sneezing, cough and occasional sleeplessness

Dosage and Administration

■ Shake well before using. ■ Measure only with the dosing syringe provided. ■ Do not use dosing syringe with other products. ■ On dosing syringe, mL = milliliter. Children under 6 months Consult a physician. Children 6 months to under 1 year 2.5 mL at bedtime and every 6 hours during the night until relieved. Children 1 year to 3 years 5 mL at bedtime and every 4 hours during the night until relieved.


Medication Information

Indications and Usage

Added bullet

Purpose

Relieves mucus, congestion, runny nose, sneezing, cough and occasional sleeplessness

Dosage and Administration

■ Shake well before using. ■ Measure only with the dosing syringe provided. ■ Do not use dosing syringe with other products. ■ On dosing syringe, mL = milliliter. Children under 6 months Consult a physician. Children 6 months to under 1 year 2.5 mL at bedtime and every 6 hours during the night until relieved. Children 1 year to 3 years 5 mL at bedtime and every 4 hours during the night until relieved.

Description

Relieves mucus, congestion, runny nose, sneezing, cough and occasional sleeplessness

Uses

■ Temporarily relieves symptoms of common cold in children at night, including: ■ accumulation of mucus in chest, throat or nose

■ cough with mucus ■ runny nose ■ sneezing ■ nasal or chest congestion ■ occasional sleeplessness

Section 42229-5

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Section 51945-4

Section 55106-9

Active ingredients

Purpose

Allium Cepa 6X HPUS

runny nose with mucus, hacking cough, sore throat

Bryonia Alba 6X HPUS

stubborn mucus in throat, cough with mucus

Chamomilla 3X HPUS

occasional sleeplessness

Coffea Cruda 3X HPUS

occasional sleeplessness

Euphrasia Officinalis 6X HPUS

cough with mucus in chest

Hepar Sulph Calc 12X HPUS

cough up mucus, mucus rattle with cough, stubborn mucus in chest

Hydrastis 6X HPUS

cough with mucus, dry/sore throat, occasional sleeplessness due to mucus in throat

Natrum Muriaticum 6X HPUS

accumulation of mucus in throat, cough up mucus

Phosphorus 30X HPUS

cough with mucus, chest congestion

Pulsatilla 6X HPUS

accumulation of mucus, discharge of mucus, loose cough

Rumex Crispus 6X HPUS

runny nose, sneezing

Silicea 12X HPUS

nasal congestion

Sulfur 12X HPUS

cough with thick mucus, chest congestion, nasal congestion

Directions

■ Use as directed. ■ Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing syringe provided. ■ Do not use dosing syringe with other products. ■ On dosing syringe, mL = milliliter.

Children under 6 months Ask a doctor before use.
Children 6 months

to under 1 year
2.5 mL at bedtime and every 6 hours

during the night until relieved.
Children 1 year

to under 3 years
5 mL at bedtime and every 4 hours

during the night until relieved.

Questions?

www.hylands.com or [email protected]

Inactive Ingredients

Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

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.

Stop Use and Ask A Doctor If:

■ symptoms persist for more than 72 hours 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 asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).

Dosage and Administration (directions)

■ Shake well before using.

■ Measure only with the dosing syringe provided.

■ Do not use dosing syringe with other products.

■ On dosing syringe, mL = milliliter.

Children under

6 months

Consult a physician.

Children 6 months

to under 1 year

2.5 mL at bedtime and every

6 hours during the night

until relieved.

Children 1 year

to 3 years

5 mL at bedtime and every

4 hours during the night

until relieved.


Structured Label Content

Uses

■ Temporarily relieves symptoms of common cold in children at night, including: ■ accumulation of mucus in chest, throat or nose

■ cough with mucus ■ runny nose ■ sneezing ■ nasal or chest congestion ■ occasional sleeplessness

Section 42229-5 (42229-5)

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active ingredients

Purpose

Allium Cepa 6X HPUS

runny nose with mucus, hacking cough, sore throat

Bryonia Alba 6X HPUS

stubborn mucus in throat, cough with mucus

Chamomilla 3X HPUS

occasional sleeplessness

Coffea Cruda 3X HPUS

occasional sleeplessness

Euphrasia Officinalis 6X HPUS

cough with mucus in chest

Hepar Sulph Calc 12X HPUS

cough up mucus, mucus rattle with cough, stubborn mucus in chest

Hydrastis 6X HPUS

cough with mucus, dry/sore throat, occasional sleeplessness due to mucus in throat

Natrum Muriaticum 6X HPUS

accumulation of mucus in throat, cough up mucus

Phosphorus 30X HPUS

cough with mucus, chest congestion

Pulsatilla 6X HPUS

accumulation of mucus, discharge of mucus, loose cough

Rumex Crispus 6X HPUS

runny nose, sneezing

Silicea 12X HPUS

nasal congestion

Sulfur 12X HPUS

cough with thick mucus, chest congestion, nasal congestion

Purpose

Relieves mucus, congestion, runny nose, sneezing, cough and occasional sleeplessness

Directions

■ Use as directed. ■ Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing syringe provided. ■ Do not use dosing syringe with other products. ■ On dosing syringe, mL = milliliter.

Children under 6 months Ask a doctor before use.
Children 6 months

to under 1 year
2.5 mL at bedtime and every 6 hours

during the night until relieved.
Children 1 year

to under 3 years
5 mL at bedtime and every 4 hours

during the night until relieved.

Questions?

www.hylands.com or [email protected]

Inactive Ingredients (Inactive ingredients)

Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

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.

Indications and Usage

Added bullet

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

■ symptoms persist for more than 72 hours 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 asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).

Dosage and Administration (directions) (Dosage and Administration (Directions))

■ Shake well before using.

■ Measure only with the dosing syringe provided.

■ Do not use dosing syringe with other products.

■ On dosing syringe, mL = milliliter.

Children under

6 months

Consult a physician.

Children 6 months

to under 1 year

2.5 mL at bedtime and every

6 hours during the night

until relieved.

Children 1 year

to 3 years

5 mL at bedtime and every

4 hours during the night

until relieved.


Advanced Ingredient Data


Raw Label Data

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