Baby Tiny Cold Tablets Combo Pack

Baby Tiny Cold Tablets Combo Pack
SPL v9
SPL
SPL Set ID be7cff09-ecff-48bd-96d4-dc7d47db7656
Route
ORAL
Published
Effective Date 2023-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eupatorium Perfoliatum Flowering Top (6 [hp_X]) Euphrasia Stricta Gelsemium Sempervirens Root Iodide Ion Matricaria Recutita
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 2017-01-11
Description

Daytime Uses  Temporarily relieves symptoms of common cold in children, including:  runny nose or eyes  nasal congestion  headache  sneezing  cough Nighttime Uses ■ Temporarily relieves symptoms of common cold in children at night, including: ■ runny nose or eyes ■ cough ■ nasal congestion ■ headache ■ sneezing ■ occasional sleeplessness ■ 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. If symptoms persist, 2 tablets every 4 hours until relieved. Children 1 year to under 3 years: At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved.

Indications and Usage

Daytime Uses  Temporarily relieves symptoms of common cold in children, including:  runny nose or eyes  nasal congestion  headache  sneezing  cough Nighttime Uses ■ Temporarily relieves symptoms of common cold in children at night, including: ■ runny nose or eyes ■ cough ■ nasal congestion ■ headache ■ sneezing ■ occasional sleeplessness ■ 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. If symptoms persist, 2 tablets every 4 hours until relieved. Children 1 year to under 3 years: At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved.

Medication Information

Indications and Usage

Daytime Uses

 Temporarily relieves symptoms of common cold in children, including:

 runny nose or eyes  nasal congestion  headache  sneezing  cough

Nighttime Uses

■ Temporarily relieves symptoms of common cold in children at night, including: ■ runny nose or eyes ■ cough ■ nasal congestion ■ headache ■ sneezing ■ occasional sleeplessness

■ 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. If symptoms persist, 2 tablets every 4 hours until relieved.



Children 1 year to under 3 years: At onset of symptoms, dissolve 3 tablets on tongue



every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved.

Description

Daytime Uses  Temporarily relieves symptoms of common cold in children, including:  runny nose or eyes  nasal congestion  headache  sneezing  cough Nighttime Uses ■ Temporarily relieves symptoms of common cold in children at night, including: ■ runny nose or eyes ■ cough ■ nasal congestion ■ headache ■ sneezing ■ occasional sleeplessness ■ 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. If symptoms persist, 2 tablets every 4 hours until relieved. Children 1 year to under 3 years: At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved.

Uses

■ Helps temporarily relieve symptoms of common cold in children, including: ■ runny nose or eyes ■ nasal congestion ■ headache ■ sneezing ■ cough

Section 55105-1

Helps temporarily relieve symptoms of common cold in children at night, including: runny nose or eyes, cough, nasal congestion,

headache, sneezing, occasional sleeplessness.

Section 55106-9
Active ingredients Purpose
Eupatorium Perfoliatum 6X HPUS headache, cough, sneezing
Euphrasia Officinalis 6X HPUS runny eyes/nose
Gelsemium Sempervirens 6X HPUS sneezing, nasal congestion
Kali Iodatum 6X HPUS headache, runny eyes/nose

"HPUS” is the 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. If symptoms persist, 2 tablets every 4 hours until relieved.
Children 1 year to under 3 years: At onset of symptoms, dissolve 3 tablets on tongue every hour

up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved.

Questions?

www.hylands.com or [email protected]

Inactive Ingredients

Acacia Gum, Lactose.

Principal Display Panel

Hyland's

•baby•

Tiny Cold Tablets*

COMBO PACK

NO ARTIFICIAL FLAVORS, PARABENS or DYES

DAYTIME

Nasal Congestion

Runny Nose

Sneezing

Cough

NIGHTTIME

Sleeplessness

Nasal Congestion

Runny Nose

Sneezing

Cough

6+ MONTHS

2 x 125 CT BOTTLES

(1 DAY, 1 NIGHT)

QUICK-DISSOLVING TABLETS

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: ■ runny nose or eyes ■ nasal congestion ■ headache ■ sneezing ■ cough

Section 55105-1 (55105-1)

Helps temporarily relieve symptoms of common cold in children at night, including: runny nose or eyes, cough, nasal congestion,

headache, sneezing, occasional sleeplessness.

Section 55106-9 (55106-9)
Active ingredients Purpose
Eupatorium Perfoliatum 6X HPUS headache, cough, sneezing
Euphrasia Officinalis 6X HPUS runny eyes/nose
Gelsemium Sempervirens 6X HPUS sneezing, nasal congestion
Kali Iodatum 6X HPUS headache, runny eyes/nose

"HPUS” is the 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. If symptoms persist, 2 tablets every 4 hours until relieved.
Children 1 year to under 3 years: At onset of symptoms, dissolve 3 tablets on tongue every hour

up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved.

Questions?

www.hylands.com or [email protected]

Inactive Ingredients (Inactive ingredients)

Acacia Gum, Lactose.

Indications and Usage

Daytime Uses

 Temporarily relieves symptoms of common cold in children, including:

 runny nose or eyes  nasal congestion  headache  sneezing  cough

Nighttime Uses

■ Temporarily relieves symptoms of common cold in children at night, including: ■ runny nose or eyes ■ cough ■ nasal congestion ■ headache ■ sneezing ■ occasional sleeplessness

■ 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. If symptoms persist, 2 tablets every 4 hours until relieved.



Children 1 year to under 3 years: At onset of symptoms, dissolve 3 tablets on tongue



every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved.

Principal Display Panel

Hyland's

•baby•

Tiny Cold Tablets*

COMBO PACK

NO ARTIFICIAL FLAVORS, PARABENS or DYES

DAYTIME

Nasal Congestion

Runny Nose

Sneezing

Cough

NIGHTTIME

Sleeplessness

Nasal Congestion

Runny Nose

Sneezing

Cough

6+ MONTHS

2 x 125 CT BOTTLES

(1 DAY, 1 NIGHT)

QUICK-DISSOLVING TABLETS

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:01.025316 · Updated: 2026-03-14T23:17:20.751290