hyland's naturals kids cold & cough nighttime

hyland's naturals kids cold & cough nighttime
SPL v11
SPL
SPL Set ID 71e93027-33c9-6147-e053-2a95a90aaa09
Route
oral
Published
Effective Date 2021-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
onion (6 [hp_X]) calcium sulfide (12 [hp_X]) chloride ion anemone pulsatilla matricaria chamomilla goldenseal arabica coffee bean phosphorus sulfur
Inactive Ingredients
water glycyrrhiza glabra glycerin citric acid monohydrate sodium benzoate

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2018-07-01 Until 2021-12-15

Indications and Usage

Change to Temporarily relieves the symptoms of the common cold, including: cough runny nose post nasal drip sneezing nasal or chest congestion sore throat with accompanying occasional sleeplessness

Dosage and Administration

Updates Shake well before using. Measure only with the dosing cup provided. Do not use dosing cup with other products. On dosing cup, mL = milliliter. 5 mL at bedtime and every 4 hours during the night until relieved 10 mL at bedtime and every 4 hours during the night until relieved 15 mL at bedtime and every 4 hours during the night until relieved

Description

Temporarily relieves symptoms of cough, runny nose, post nasal drip, sneezing, sore throat, nasal or chest congestion, and occasional sleeplessness.


Medication Information

Active Ingredient

Active ingredients

Purpose*

Allium Cepa 6X HPUS

watery/runny nose, cold, hacking cough, painful throat

Chamomilla 6X HPUS

occasional sleeplessness

Coffea Cruda 6X HPUS

occasional sleeplessness

Hepar Sulph Calc 12X HPUS

cold, sneezing

Hydrastis 6X HPUS

rattling/tickling cough, sinus congestion, dry/raw/sore throat

Natrum Muriaticum 6X HPUS

dry cough, sore throat

Phosphorus 12X HPUS

hoarse/dry cough, nasal congestion, chest congestion

Pulsatilla 6X HPUS

moist cough, cold, post nasal drip

Sulphur 12X HPUS

chest congestion, nasal congestion, sneezing, runny nose

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Indications and Usage

Change to Temporarily relieves the symptoms of the common cold, including: cough runny nose post nasal drip sneezing nasal or chest congestion sore throat with accompanying occasional sleeplessness

Directions

■ Use as directed. ■ Do not refrigerate. ■ Shake well before using.

■ Measure only with dosing cup provides. ■ Do not use dosing cup with other products.

■ On dosing cup, mL = milliliter.

Children 2 years

to under 6 years

5 mL at bedtime and every 4 hours

during the night until relieved.

Children 6 years

to under 12 years

10 mL at bedtime and every 4 hours

during the night until relieved.

Adults and children

12 years and over

15 mL at bedtime and every 4 hours

during the night until relieved.

Dosage and Administration

Updates Shake well before using. Measure only with the dosing cup provided. Do not use dosing cup with other products. On dosing cup, mL = milliliter. 5 mL at bedtime and every 4 hours during the night until relieved 10 mL at bedtime and every 4 hours during the night until relieved 15 mL at bedtime and every 4 hours during the night until relieved

Inactive Ingredients

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

Description

Temporarily relieves symptoms of cough, runny nose, post nasal drip, sneezing, sore throat, nasal or chest congestion, and occasional sleeplessness.

Questions?

www.hylands.com or [email protected]

Uses*

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

■ cough ■ runny nose ■ post nasal drip ■ sneezing ■ sore throat

■ nasal or chest congestion ■ occasional sleeplessness

Section 55105-1

Temporarily relieves symptoms of cough, runny nose, post nasal drip, sneezing, sore throat, nasal or chest congestion, and occasional sleeplessness.

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.

If Pregnant Or Breastfeeding

Ask a health professional before use.

Indications and Usage "uses"

Change to

  • Temporarily relieves the symptoms of the common cold, including:
  • cough
  • runny nose
  • post nasal drip
  • sneezing
  • nasal or chest congestion
  • sore throat with accompanying occasional sleeplessness
Stop Use and Ask A Doctor If

■ symptoms persist for more than 7 days 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.

Ask A Doctor Before Use If You Have

■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).

Dosage and Administration "directions"

Updates

  • Shake well before using.
  • Measure only with the dosing cup provided.
  • Do not use dosing cup with other products.
  • On dosing cup, mL = milliliter.

5 mL at bedtime and every

4 hours during the night

until relieved

10 mL at bedtime and every

4 hours during the night

until relieved

15 mL at bedtime and every

4 hours during the night

until relieved

*claims Based On Traditional Homeopathic Practice,

Principal Display Panel 4 Fl. Oz. (118 Ml) Carton

Hyland's

NATURALS™

•Kids•

Cold &

Cough*

NIGHTTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES

Sleeplessness*

Congestion*

Runny Nose*

Sore Throat*

Cough*

Post Nasal

Drip*

2-12

YEARS

4 FL. OZ. (118 mL)

HOMEOPATHIC

Do Not Use If Tamper Evident Seal Is Broken Or Missing.


Structured Label Content

Active Ingredient (55106-9)

Active ingredients

Purpose*

Allium Cepa 6X HPUS

watery/runny nose, cold, hacking cough, painful throat

Chamomilla 6X HPUS

occasional sleeplessness

Coffea Cruda 6X HPUS

occasional sleeplessness

Hepar Sulph Calc 12X HPUS

cold, sneezing

Hydrastis 6X HPUS

rattling/tickling cough, sinus congestion, dry/raw/sore throat

Natrum Muriaticum 6X HPUS

dry cough, sore throat

Phosphorus 12X HPUS

hoarse/dry cough, nasal congestion, chest congestion

Pulsatilla 6X HPUS

moist cough, cold, post nasal drip

Sulphur 12X HPUS

chest congestion, nasal congestion, sneezing, runny nose

“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 dosing cup provides. ■ Do not use dosing cup with other products.

■ On dosing cup, mL = milliliter.

Children 2 years

to under 6 years

5 mL at bedtime and every 4 hours

during the night until relieved.

Children 6 years

to under 12 years

10 mL at bedtime and every 4 hours

during the night until relieved.

Adults and children

12 years and over

15 mL at bedtime and every 4 hours

during the night until relieved.

Inactive Ingredients (Inactive ingredients)

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

Questions?

www.hylands.com or [email protected]

Uses*

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

■ cough ■ runny nose ■ post nasal drip ■ sneezing ■ sore throat

■ nasal or chest congestion ■ occasional sleeplessness

Section 55105-1 (55105-1)

Temporarily relieves symptoms of cough, runny nose, post nasal drip, sneezing, sore throat, nasal or chest congestion, and occasional sleeplessness.

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.

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

Ask a health professional before use.

Indications and Usage "uses" (Indications and Usage "Uses")

Change to

  • Temporarily relieves the symptoms of the common cold, including:
  • cough
  • runny nose
  • post nasal drip
  • sneezing
  • nasal or chest congestion
  • sore throat with accompanying occasional sleeplessness
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ symptoms persist for more than 7 days 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.)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).

Dosage and Administration "directions" (Dosage and Administration "Directions")

Updates

  • Shake well before using.
  • Measure only with the dosing cup provided.
  • Do not use dosing cup with other products.
  • On dosing cup, mL = milliliter.

5 mL at bedtime and every

4 hours during the night

until relieved

10 mL at bedtime and every

4 hours during the night

until relieved

15 mL at bedtime and every

4 hours during the night

until relieved

*claims Based On Traditional Homeopathic Practice, (*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,)

Principal Display Panel 4 Fl. Oz. (118 Ml) Carton (PRINCIPAL DISPLAY PANEL - 4 FL. OZ. (118 mL) Carton)

Hyland's

NATURALS™

•Kids•

Cold &

Cough*

NIGHTTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES

Sleeplessness*

Congestion*

Runny Nose*

Sore Throat*

Cough*

Post Nasal

Drip*

2-12

YEARS

4 FL. OZ. (118 mL)

HOMEOPATHIC

Do Not Use If Tamper Evident Seal Is Broken Or Missing. (DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.)


Advanced Ingredient Data


Raw Label Data

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