Hyland's Naturals Baby Tiny Cold Tablets Nighttime

Hyland's Naturals Baby Tiny Cold Tablets Nighttime
SPL v8
SPL
SPL Set ID 275f18d5-739e-4055-9553-10ae2be836ad
Route
ORAL
Published
Effective Date 2016-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Matricaria Recutita (6 [hp_X]) Eupatorium Perfoliatum Flowering Top Euphrasia Stricta Gelsemium Sempervirens Root Iodide Ion
Inactive Ingredients
Acacia Lactose, Unspecified Form

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 5 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-12-28 Until 2021-12-27

Description

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

Indications and Usage

■ Temporarily relieves symptoms of common cold in children at night, including: ■ runny nose or eyes ■ cough ■ nasal congestion ■ headache ■ sneezing ■ occasional sleeplessness Directions ■ Use as directed. Children under 6 months Ask a doctor before use. Children 6 months to under 1 year At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours as needed. If symptoms persist, 2 tablets every 4 hours during the night until relieved. Children 1 year to under 3 years At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist, 3 tablets every 4 hours during the night until relieved.


Medication Information

Indications and Usage

■ Temporarily relieves symptoms of common cold in children at night, including: ■ runny nose or eyes ■ cough ■ nasal congestion ■ headache ■ sneezing ■ occasional sleeplessness Directions ■ Use as directed. Children under 6 months Ask a doctor before use. Children 6 months to under 1 year At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours as needed. If symptoms persist, 2 tablets every 4 hours during the night until relieved. Children 1 year to under 3 years At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist, 3 tablets every 4 hours during the night until relieved.

Description

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

Uses

■ Temporarily relieves symptoms of common cold in children at night, including:

■ runny nose or eyes ■ cough ■ nasal congestion

■ headache ■ sneezing ■ occasional sleeplessness

Section 55105-1

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

Section 55106-9

Active ingredients

Purpose

Chamomilla 6X HPUS

occasional sleeplessness

Eupatorium Perfoliatum 6X HPUS

headache, cough, sneezing

Euphrasia Officinalis 6X HPUS

runny eyes/nose, nighttime coughing

Gelsemium Sempervirens 6X HPUS

sneezing, nasal congestion,occasional sleeplessness

Kali Iodatum 6X HPUS headache, runny eyes/nose

"HPUS" indicates that the active ingredients are in the official Homeopathic

Pharmacopoeia of the United States.

Directions

■ Use as directed.

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

to under 1 year
At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,

2 tablets every 4 hours during the night until relieved.
Children 1 year

to under 3 years
At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,

3 tablets every 4 hours during the night until relieved.

Questions?

(800) 624-9659

Inactive Ingredients

Acacia Gum, Lactose.

Indications and Usage ( Uses

■ Temporarily relieves symptoms of common cold in children at night, including:

■ runny nose or eyes ■ cough ■ nasal congestion

■ headache ■ sneezing ■ occasional sleeplessness

Directions

■ Use as directed.

Children under 6 months

Ask a doctor before use.

Children 6 months

to under 1 year

At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,

2 tablets every 4 hours during the night until relieved.

Children 1 year

to under 3 years

At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,

3 tablets every 4 hours during the night until relieved.

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).

Principal Display Panel 125 Tablet Bottle Carton

Hyland's

NATURALS™

•baby•

Tiny Cold

Tablets*

Nighttime

NO ARTIFICIAL FLAVORS,

DYES or PARABENS

Sleeplessness

Nasal Congestions

Runny Nose

Sneezing

Cough

6+ MONTHS

125

QUICK-DISSOLVING TABLETS

HOMEOPATHIC


Structured Label Content

Uses

■ Temporarily relieves symptoms of common cold in children at night, including:

■ runny nose or eyes ■ cough ■ nasal congestion

■ headache ■ sneezing ■ occasional sleeplessness

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

Active ingredients

Purpose

Chamomilla 6X HPUS

occasional sleeplessness

Eupatorium Perfoliatum 6X HPUS

headache, cough, sneezing

Euphrasia Officinalis 6X HPUS

runny eyes/nose, nighttime coughing

Gelsemium Sempervirens 6X HPUS

sneezing, nasal congestion,occasional sleeplessness

Kali Iodatum 6X HPUS headache, runny eyes/nose

"HPUS" indicates that the active ingredients are in the official Homeopathic

Pharmacopoeia of the United States.

Directions

■ Use as directed.

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

to under 1 year
At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,

2 tablets every 4 hours during the night until relieved.
Children 1 year

to under 3 years
At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,

3 tablets every 4 hours during the night until relieved.

Questions?

(800) 624-9659

Inactive Ingredients (Inactive ingredients)

Acacia Gum, Lactose.

Indications and Usage ( Uses

■ Temporarily relieves symptoms of common cold in children at night, including:

■ runny nose or eyes ■ cough ■ nasal congestion

■ headache ■ sneezing ■ occasional sleeplessness

Directions

■ Use as directed.

Children under 6 months

Ask a doctor before use.

Children 6 months

to under 1 year

At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,

2 tablets every 4 hours during the night until relieved.

Children 1 year

to under 3 years

At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,

3 tablets every 4 hours during the night until relieved.

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).

Principal Display Panel 125 Tablet Bottle Carton (PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton)

Hyland's

NATURALS™

•baby•

Tiny Cold

Tablets*

Nighttime

NO ARTIFICIAL FLAVORS,

DYES or PARABENS

Sleeplessness

Nasal Congestions

Runny Nose

Sneezing

Cough

6+ MONTHS

125

QUICK-DISSOLVING TABLETS

HOMEOPATHIC


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)