Hyland's Naturals Baby Mucus + Cold Relief Combo Pack Daytime & Nighttime

Hyland's Naturals Baby Mucus + Cold Relief Combo Pack Daytime & Nighttime
SPL v7
SPL
SPL Set ID 7979fc6f-6d2c-56c9-e053-2991aa0ac1f3
Route
ORAL
Published
Effective Date 2023-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-11-01

Description

Active ingredients Purpose* Bryonia Alba 6X HPUS stubborn mucus in throat, cough with mucus 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 Natrum Muriaticum 30X 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 HPUS" is the Homeopathic Pharmacopoeia of the United States.

Indications and Usage

Added asterisk (*) to Uses for Daytime and Nighttime


Medication Information

Indications and Usage

Added asterisk (*) to Uses for Daytime and Nighttime

Description

Active ingredients Purpose* Bryonia Alba 6X HPUS stubborn mucus in throat, cough with mucus 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 Natrum Muriaticum 30X 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 HPUS" is the Homeopathic Pharmacopoeia of the United States.

Uses*

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

■ accumulation of mucus in chest, throat or nose

■ cough with mucus ■ runny nose ■ sneezing

■ nasal or chest congestion

Section 55105-1

Helps temporarily relieve 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 55106-9
Active ingredients Purpose*
Bryonia Alba 6X HPUS stubborn mucus in throat, cough with mucus
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
Natrum Muriaticum 30X 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

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 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 up to 4 times per day

(every 6 hours).
Children 1 year

to under 3 years
5 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, Purified Water, Sodium Benzoate.

Principal Display Panel

Hyland's

NATURALS™

•baby•

Mucus + Cold Relief*

COMBO PACK

NO SUGAR, PARABENS or DYES

DAYTIME

Mucus*

Congestion*

Runny Nose*

Sneezing*

Cough*

NIGHTTIME

Sleeplessness*

Mucus*

Congestion*

Runny Nose*

Sneezing*

Cough*

6+ MONTHS

DAYTIME - NO ALCOHOL

NIGHTTIME - LESS THAN 0.2% ALCOHOL

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

HOMEOPATHIC

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).


Structured Label Content

Uses*

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

■ accumulation of mucus in chest, throat or nose

■ cough with mucus ■ runny nose ■ sneezing

■ nasal or chest congestion

Section 55105-1 (55105-1)

Helps temporarily relieve 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 55106-9 (55106-9)
Active ingredients Purpose*
Bryonia Alba 6X HPUS stubborn mucus in throat, cough with mucus
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
Natrum Muriaticum 30X 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

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 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 up to 4 times per day

(every 6 hours).
Children 1 year

to under 3 years
5 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, Purified Water, Sodium Benzoate.

Indications and Usage

Added asterisk (*) to Uses for Daytime and Nighttime

Principal Display Panel

Hyland's

NATURALS™

•baby•

Mucus + Cold Relief*

COMBO PACK

NO SUGAR, PARABENS or DYES

DAYTIME

Mucus*

Congestion*

Runny Nose*

Sneezing*

Cough*

NIGHTTIME

Sleeplessness*

Mucus*

Congestion*

Runny Nose*

Sneezing*

Cough*

6+ MONTHS

DAYTIME - NO ALCOHOL

NIGHTTIME - LESS THAN 0.2% ALCOHOL

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

HOMEOPATHIC

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).


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)