2 To 12 Years

2 To 12 Years
SPL v2
SPL
SPL Set ID 75ad8ebf-c8f2-4f9b-802b-fe63fc985ede
Route
ORAL
Published
Effective Date 2024-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Onion (6 [hp_X]) Goldenseal (12 [hp_X]) Calcium Sulfide Chloride Ion Phosphorus Anemone Pulsatilla Sulfur Matricaria Chamomilla Arabica Coffee Bean
Inactive Ingredients
Citric Acid Monohydrate Glycerin Water Glycyrrhiza Glabra Sodium Benzoate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-12-28

Description

Active ingredients Purpose Allium Cepa 6X HPUS watery/runny nose, cold, hacking cough, painful throat 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, nasal congestion Sulphur 12X HPUS chest congestion, nasal congestion, sneezing, runny nose


Medication Information

Warnings and Precautions

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

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly.

In case of emergency, contact a medical professional or Poison Control Center immediately.

Description

Active ingredients Purpose Allium Cepa 6X HPUS watery/runny nose, cold, hacking cough, painful throat 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, nasal congestion Sulphur 12X HPUS chest congestion, nasal congestion, sneezing, runny nose

Uses
  • temporarily relieves the symptoms of common cold including nasal and chest congestion, runny nose, sore throat, sneezing and cough.
Section 42229-5

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

Section 50565-1

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately.

Section 50569-3

Consult a physician if:

  • symptoms persistent for more than 7 days or worsen
  • inflammation, fever or infection develops
  • symptoms are accompanied by high fever (over 101° F)
  • cough tends to recur or is accompanied by 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 medical 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 55106-9

Active ingredients

Purpose

Allium Cepa 6X HPUS

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

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, nasal congestion

Sulphur 12X HPUS

chest congestion, nasal congestion, sneezing, runny nose

Section 60561-8

TAMPER-EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND OR SEAL UNDER CAP IS BROKEN OR MISSING

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.

Package Label Kit Carton

CHILDREN'S COLD & COUGH 

Sugar Free, Dye Free

Alcohol free

DAYTIME

Cough

Nasal Congestion

Runny Nose

Sore Throat

Sneezing

NIGHTTIME

Cough

Sneezing

Runny Nose

Sleeplessness

Sore Throat

2-12 YEARS

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

HOMEOPATHIC


Structured Label Content

Uses
  • temporarily relieves the symptoms of common cold including nasal and chest congestion, runny nose, sore throat, sneezing and cough.
Warnings and Precautions (34071-1)

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

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly.

In case of emergency, contact a medical professional or Poison Control Center immediately.

Section 42229-5 (42229-5)

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

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 a poison control center immediately.

Section 50569-3 (50569-3)

Consult a physician if:

  • symptoms persistent for more than 7 days or worsen
  • inflammation, fever or infection develops
  • symptoms are accompanied by high fever (over 101° F)
  • cough tends to recur or is accompanied by 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 medical 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 55106-9 (55106-9)

Active ingredients

Purpose

Allium Cepa 6X HPUS

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

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, nasal congestion

Sulphur 12X HPUS

chest congestion, nasal congestion, sneezing, runny nose

Section 60561-8 (60561-8)

TAMPER-EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND OR SEAL UNDER CAP IS BROKEN OR MISSING

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.

Package Label Kit Carton (PACKAGE LABEL - KIT CARTON)

CHILDREN'S COLD & COUGH 

Sugar Free, Dye Free

Alcohol free

DAYTIME

Cough

Nasal Congestion

Runny Nose

Sore Throat

Sneezing

NIGHTTIME

Cough

Sneezing

Runny Nose

Sleeplessness

Sore Throat

2-12 YEARS

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

HOMEOPATHIC


Advanced Ingredient Data


Raw Label Data

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