Hyland's Naturals Baby Mucus + Cold Relief Daytime

Hyland's Naturals Baby Mucus + Cold Relief Daytime
SPL v12
SPL
SPL Set ID d934cc8a-1e43-4942-858a-05b5d068679a
Route
ORAL
Published
Effective Date 2023-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bryonia Alba Root (6 [hp_X]) Euphrasia Stricta (12 [hp_X]) Calcium Sulfide (30 [hp_X]) Sodium Cation Phosphorus Anemone Pulsatilla Silicon Dioxide Rumex Crispus Root
Inactive Ingredients
Citric Acid Monohydrate Glycerin Licorice Water Sodium Benzoate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-05-13 Until 2021-12-20

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

Uses*


Medication Information

Indications and Usage

Uses*

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 42229-5

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

Section 55105-1

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 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]

Inactive Ingredients

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

Principal Display Panel

Hyland's

NATURALS™

•baby•

Mucus + Cold

Relief

D AYTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES

Mucus*

Congestion*

Runny Nose*

Sneezing*

Cough*

6+ MONTHS

4 FL. OZ. (118 mL)

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 42229-5 (42229-5)

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

Section 55105-1 (55105-1)

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 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]

Inactive Ingredients (Inactive ingredients)

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

Indications and Usage

Uses*

Principal Display Panel

Hyland's

NATURALS™

•baby•

Mucus + Cold

Relief

D AYTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES

Mucus*

Congestion*

Runny Nose*

Sneezing*

Cough*

6+ MONTHS

4 FL. OZ. (118 mL)

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

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