2 To 12 Years

2 To 12 Years
SPL v2
SPL
SPL Set ID 16fc90ae-a919-4654-b635-d7b54923d448
Route
ORAL
Published
Effective Date 2024-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Matricaria Chamomilla (3 [hp_X]) Chloride Ion (6 [hp_X]) Sulfur (12 [hp_X]) Rumex Crispus Root (30 [hp_X]) Onion Bryonia Alba Root Euphrasia Stricta Goldenseal Phosphorus Arabica Coffee Bean Calcium Sulfide Silicon Dioxide Anemone Pulsatilla
Inactive Ingredients
Glycyrrhiza Glabra Sodium Benzoate Water Citric Acid Monohydrate Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-12-29

Description

Bryonia Alba 6X HPUS ................................. stubborn mucus in throat, cough with yellowish 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 expectoration of yellow mucus, chest congestion Pulsatilla 6X HPUS ........................................ accumulation of mucus, discharge of thick yellowish mucus, loose cough Rumex Crispus 6X HPUS .............................. runny nose, sneezing Silicea 12X HPUS ......................................... nasal congestion “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Purpose

Allium Cepa 6X HPUS ..................... runny nose with mucus, hacking cough, sore throat Bryonia Alba 6X HPUS .................... stubborn mucus in throat, cough wilh yellowish mucus Chamomilla 3X HPUS ..................... irritabilily, fussiness, occasional sleeplessness Collea Cruda 3X HPUS .................... occasional sleeplessness, restlessness 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 Hydrastis 6X HPUS ........................... cough with mucus, dry, sore throat, occasional sleeplessness due to mucus in throat Natrum Muriaticum 6X HPUS ............ accumulation of mucus in throat, cough up mucus Phosphorus 30X HPUS ...................... cough with expectoration of yellow mucus, chest congestion Pulsatilla 6X HPUS ........................... accumulation of mucus, discharge of thick yellowish mucus, loose cough Rumex Crispus 6X HPUS ................... runny nose, sneezing Silicea 12X HPUS ............................... nasal congestion Sulphur 12X HPUS ............................ cough with thick mucus, chest congestion, nasal congestion “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.


Medication Information

Purpose

Allium Cepa 6X HPUS ..................... runny nose with mucus, hacking cough, sore throat Bryonia Alba 6X HPUS .................... stubborn mucus in throat, cough wilh yellowish mucus Chamomilla 3X HPUS ..................... irritabilily, fussiness, occasional sleeplessness Collea Cruda 3X HPUS .................... occasional sleeplessness, restlessness 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 Hydrastis 6X HPUS ........................... cough with mucus, dry, sore throat, occasional sleeplessness due to mucus in throat Natrum Muriaticum 6X HPUS ............ accumulation of mucus in throat, cough up mucus Phosphorus 30X HPUS ...................... cough with expectoration of yellow mucus, chest congestion Pulsatilla 6X HPUS ........................... accumulation of mucus, discharge of thick yellowish mucus, loose cough Rumex Crispus 6X HPUS ................... runny nose, sneezing Silicea 12X HPUS ............................... nasal congestion Sulphur 12X HPUS ............................ cough with thick mucus, chest congestion, nasal congestion “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Description

Bryonia Alba 6X HPUS ................................. stubborn mucus in throat, cough with yellowish 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 expectoration of yellow mucus, chest congestion Pulsatilla 6X HPUS ........................................ accumulation of mucus, discharge of thick yellowish mucus, loose cough Rumex Crispus 6X HPUS .............................. runny nose, sneezing Silicea 12X HPUS ......................................... nasal congestion “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses
  • Temporarily relieves the symptoms of colds including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing and nasal congestion.
Section 42229-5

A persistent cough may be a sign of a serious condition.

Section 50565-1

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Section 50569-3

Consult a physician if:

  • symptoms persist for more than 7 days or worsen.
  • inflammation, fever or infection develops.
  • symptoms are accompanied by a high fever (over 101°F).
  • cough tends to recur or is accompanied by a high fever,rash or persistent headache.
Section 50570-1

Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a licensed health care professional.

Section 53413-1

Questions or comments?

Call 1-866-254-3900.

Section 53414-9

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Section 55105-1

LOOSENS MUCUS IN CHEST, THROAT AND NOSE

Directions
  • Measure only with the dosing cup provided
  • Do not use dosing cup with other products
  • On dosing cup, mL = milliliter, tsp = teaspoon

Children 2 years

to under 6 years

1 teaspoon or 5 mL up to

6 times per day (every 4 hours)

Children 6 years

to under 12 years

2 teaspoons or 10 mL up to

6 times per day (every 4 hours)

Adults and children

12 years and over

3 teaspoons or 15 mL up to

6 times per day (every 4 hours)

Inactive Ingredients

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

Principal Display Panel 

CHILDREN'S COLD & MUCUS

Sugar Free, Dye Free

Alcohol free

DAYTIME

Runny Nose

Mucus & Congestion

Cough

NIGHTTIME

Runny Nose

Mucus & Congestion

Occasional Sleeplessness

Cough

2-12 YEARS

TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)

HOMEOPATHIC

Active Ingredients                   purposes

Bryonia Alba 6X HPUS ................................. stubborn mucus in throat, cough with yellowish 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 expectoration of yellow mucus, chest congestion

Pulsatilla 6X HPUS ........................................ accumulation of mucus, discharge of thick yellowish mucus, loose cough

Rumex Crispus 6X HPUS .............................. runny nose, sneezing

Silicea 12X HPUS ......................................... nasal congestion

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

Active Ingredients                           purposes

Allium Cepa 6X HPUS ..................... runny nose with mucus, hacking cough, sore throat

Bryonia Alba 6X HPUS .................... stubborn mucus in throat, cough wilh yellowish mucus

Chamomilla 3X HPUS ..................... irritabilily, fussiness, occasional sleeplessness

Collea Cruda 3X HPUS .................... occasional sleeplessness, restlessness

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

Hydrastis 6X HPUS ........................... cough with mucus, dry, sore throat, occasional sleeplessness due to mucus in throat

Natrum Muriaticum 6X HPUS ............ accumulation of mucus in throat, cough up mucus

Phosphorus 30X HPUS ...................... cough with expectoration of yellow mucus, chest congestion

Pulsatilla 6X HPUS ........................... accumulation of mucus, discharge of thick yellowish mucus, loose cough

Rumex Crispus 6X HPUS ................... runny nose, sneezing

Silicea 12X HPUS ............................... nasal congestion

Sulphur 12X HPUS ............................ cough with thick mucus, chest congestion, nasal congestion

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


Structured Label Content

Uses
  • Temporarily relieves the symptoms of colds including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing and nasal congestion.
Section 42229-5 (42229-5)

A persistent cough may be a sign of a serious condition.

Section 50565-1 (50565-1)

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Section 50569-3 (50569-3)

Consult a physician if:

  • symptoms persist for more than 7 days or worsen.
  • inflammation, fever or infection develops.
  • symptoms are accompanied by a high fever (over 101°F).
  • cough tends to recur or is accompanied by a high fever,rash or persistent headache.
Section 50570-1 (50570-1)

Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a licensed health care professional.

Section 53413-1 (53413-1)

Questions or comments?

Call 1-866-254-3900.

Section 53414-9 (53414-9)

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Section 55105-1 (55105-1)

LOOSENS MUCUS IN CHEST, THROAT AND NOSE

Directions
  • Measure only with the dosing cup provided
  • Do not use dosing cup with other products
  • On dosing cup, mL = milliliter, tsp = teaspoon

Children 2 years

to under 6 years

1 teaspoon or 5 mL up to

6 times per day (every 4 hours)

Children 6 years

to under 12 years

2 teaspoons or 10 mL up to

6 times per day (every 4 hours)

Adults and children

12 years and over

3 teaspoons or 15 mL up to

6 times per day (every 4 hours)

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel 

CHILDREN'S COLD & MUCUS

Sugar Free, Dye Free

Alcohol free

DAYTIME

Runny Nose

Mucus & Congestion

Cough

NIGHTTIME

Runny Nose

Mucus & Congestion

Occasional Sleeplessness

Cough

2-12 YEARS

TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)

HOMEOPATHIC

Active Ingredients                   purposes (Active ingredients                   Purposes)

Bryonia Alba 6X HPUS ................................. stubborn mucus in throat, cough with yellowish 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 expectoration of yellow mucus, chest congestion

Pulsatilla 6X HPUS ........................................ accumulation of mucus, discharge of thick yellowish mucus, loose cough

Rumex Crispus 6X HPUS .............................. runny nose, sneezing

Silicea 12X HPUS ......................................... nasal congestion

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

Active Ingredients                           purposes (Active ingredients                           Purposes)

Allium Cepa 6X HPUS ..................... runny nose with mucus, hacking cough, sore throat

Bryonia Alba 6X HPUS .................... stubborn mucus in throat, cough wilh yellowish mucus

Chamomilla 3X HPUS ..................... irritabilily, fussiness, occasional sleeplessness

Collea Cruda 3X HPUS .................... occasional sleeplessness, restlessness

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

Hydrastis 6X HPUS ........................... cough with mucus, dry, sore throat, occasional sleeplessness due to mucus in throat

Natrum Muriaticum 6X HPUS ............ accumulation of mucus in throat, cough up mucus

Phosphorus 30X HPUS ...................... cough with expectoration of yellow mucus, chest congestion

Pulsatilla 6X HPUS ........................... accumulation of mucus, discharge of thick yellowish mucus, loose cough

Rumex Crispus 6X HPUS ................... runny nose, sneezing

Silicea 12X HPUS ............................... nasal congestion

Sulphur 12X HPUS ............................ cough with thick mucus, chest congestion, nasal congestion

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


Advanced Ingredient Data


Raw Label Data

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