Hyland's Naturals Baby Cough Syrup Daytime

Hyland's Naturals Baby Cough Syrup Daytime
SPL v11
SPL
SPL Set ID 2daac16d-69d0-48bf-806f-f22c0a6973ad
Route
ORAL
Published
Effective Date 2021-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ipecac (6 [hp_X]) Bryonia Alba Root (12 [hp_X]) Spongia Officinalis Skeleton, Roasted Phosphorus Causticum Drosera Rotundifolia Rumex Crispus Root
Inactive Ingredients
Licorice Water Sodium Benzoate Glycerin Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2012-10-17 Until 2021-12-28

Description

Relieves coughs in babies

Indications and Usage

Added bullet ■

Dosage and Administration

Directions updated to ■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 up to 4 times per day (every 6 hours). Children 1 year to 3 years 5 mL up to 6 times per day (every 4 hours).


Medication Information

Indications and Usage

Added bullet ■

Dosage and Administration

Directions

updated to

■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 up to 4 times per day (every 6 hours).

Children 1 year

to 3 years

5 mL up to 6 times per day (every 4 hours).

Description

Relieves coughs in babies

Uses

■ Temporarily relieves the symptoms of simple, dry, tight or tickling coughs due to colds in children.

Section 55105-1

Relieves coughs in babies

Section 55106-9

Active ingredients

Purpose

Bryonia Alba 6X HPUS

dry cough

Causticum 6X HPUS

hoarse cough

Drosera Rotundifolia 6X HPUS

barking cough

Ipecacuanha 6X

gagging cough

Phosphorus 12X HPUS

tight cough

Rumex Crispus 6X HPUS

dry cough

Spongia Tosta 6X HPUS

tickling cough

"HPUS" indicates that the active ingredients are in the official 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).

Drug Facts

Questions?

(800) 624-9659

Inactive Ingredients

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

Indications and Usage Uses

Added bullet ■

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.

Keep Out of Reach of Children.

Keep this and all medications out of the reach of children.

Package Label 118 Ml Bottle Carton

Hyland's

NATURALS™

•baby•

Cough

Syrup*

DAYTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES

6+ MONTHS

4 FL. OZ. (118 mL)

HOMEOPATHIC

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

■ Temporarily relieves the symptoms of simple, dry, tight or tickling coughs due to colds in children.

Section 55105-1 (55105-1)

Relieves coughs in babies

Section 55106-9 (55106-9)

Active ingredients

Purpose

Bryonia Alba 6X HPUS

dry cough

Causticum 6X HPUS

hoarse cough

Drosera Rotundifolia 6X HPUS

barking cough

Ipecacuanha 6X

gagging cough

Phosphorus 12X HPUS

tight cough

Rumex Crispus 6X HPUS

dry cough

Spongia Tosta 6X HPUS

tickling cough

"HPUS" indicates that the active ingredients are in the official 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).

Drug Facts

Questions?

(800) 624-9659

Inactive Ingredients (Inactive ingredients)

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

Dosage and Administration

Directions

updated to

■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 up to 4 times per day (every 6 hours).

Children 1 year

to 3 years

5 mL up to 6 times per day (every 4 hours).

Indications and Usage Uses

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.

Keep Out of Reach of Children. (Keep out of reach of children.)

Keep this and all medications out of the reach of children.

Package Label 118 Ml Bottle Carton (PACKAGE LABEL-118 mL BOTTLE CARTON)

Hyland's

NATURALS™

•baby•

Cough

Syrup*

DAYTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES

6+ MONTHS

4 FL. OZ. (118 mL)

HOMEOPATHIC

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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