2 to 12 YEARS CHILDRENS COLD and MUCUS

Manufacturer
Rite Aid Hdgrts Corp | Seaway Pharma Inc. | Bhargava Phytolab
Effective date
2024-12-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:29:51

Label at a glance#

Product2 to 12 YEARS CHILDRENS COLD and MUCUS
Active ingredientMATRICARIA CHAMOMILLA, SODIUM CHLORIDE, SULFUR, RUMEX CRISPUS ROOT, ONION, BRYONIA ALBA ROOT, EUPHRASIA STRICTA, GOLDENSEAL, PHOSPHORUS, ARABICA COFFEE BEAN, CALCIUM SULFIDE, SILICON DIOXIDE, ANEMONE PULSATILLA
Label structure5 sections

Label contents#

Full prescribing information#

DAYTIME

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients                   Purposes

OTC - ACTIVE INGREDIENT SECTION

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.

OTC - PURPOSE SECTION

LOOSENS MUCUS IN CHEST, THROAT AND NOSE

Uses

INDICATIONS & USAGE SECTION

  • 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.

Warnings

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - ASK DOCTOR SECTION

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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

OTC - DO NOT USE SECTION

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

Drug Facts (continued)

SPL UNCLASSIFIED SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 INGREDIENT SECTION

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

NIGHTTIME

SPL UNCLASSIFIED SECTION

Active ingredients                           Purposes

OTC - ACTIVE INGREDIENT SECTION

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.

OTC - PURPOSE SECTION

LOOSENS MUCUS IN CHEST, THROAT AND NOSE

Uses

INDICATIONS & USAGE SECTION

  • Temporarily relieves the symptoms of the common cold in children especially at mght including accumulation of mucus in chest, throat and nose, cough with mucus, runny nose, sneezing, nasal congestion, and occasional sleeplessness.

Drug Facts (continued)

SPL UNCLASSIFIED SECTION

Warnings

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - ASK DOCTOR SECTION

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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

OTC - DO NOT USE SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 teaspoon or 10 mL up to

6 times per day (every 4 hours)

Adults and children

12 years and over

3 teaspoon or 15 mL up to

6 times per day (every 4 hours)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments?
Call 1-866-254-3900.

SPL UNCLASSIFIED SECTION

  • THIS INFORMATION IS BASED UPON TRADITIONAL HOMEOPATHIC PRACTICE. THESE HAVE NOT BEEN REVIEWED BY FOOD AND DRUG ADMINISTRATION
  • TAMPER-EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND OR SEAL UNDER CAP IS BROKEN OR MISSING
  • This product is not manufactured or distributed by Hyland's

SPL UNCLASSIFIED SECTION

Distributed by:

RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011
www.riteaid.com

Principal Display Panel 

PACKAGE LABEL.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

cartonlabelcartonlabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-1245-42 to 12 YEARS CHILDRENS COLD and MUCUS1 in 1 CARTONLIQUID12 [hp_X] in 1mL2
11822-1245-42 to 12 YEARS CHILDRENS COLD and MUCUS118 mL in 1 BOTTLELIQUID118 mL6 [hp_X] in 1mL2
11822-2234-12 to 12 YEARS CHILDRENS COLD and MUCUS1 in 1 CARTONKIT12
11822-2245-42 to 12 YEARS CHILDRENS COLD and MUCUS1 in 1 CARTONLIQUID3 [hp_X] in 1mL2
11822-2245-42 to 12 YEARS CHILDRENS COLD and MUCUS118 mL in 1 BOTTLELIQUID118 mL12 [hp_X] in 1mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-12452 TO 12 YEARS CHILDRENS COLD AND MUCUS (EUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFUR) KIT [RITE AID HDGRTS CORP]2Unmatched20241228_16fc90ae-a919-4654-b635-d7b54923d448.zip
11822-22342 TO 12 YEARS CHILDRENS COLD AND MUCUS (EUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFUR) KIT [RITE AID HDGRTS CORP]2Legacy NDC, 5 package rows20241228_16fc90ae-a919-4654-b635-d7b54923d448.zip
11822-22452 TO 12 YEARS CHILDRENS COLD AND MUCUS (EUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFUR) KIT [RITE AID HDGRTS CORP]2Unmatched20241228_16fc90ae-a919-4654-b635-d7b54923d448.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-223411822-2234-1
11822-124511822-1245-4
11822-224511822-2245-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1307634d-2028-44e7-8eee-c36f484a53b816fc90ae-a919-4654-b635-d7b54923d4482024-12-27WarningsExact identifier
spl id: 1307634d-2028-44e7-8eee-c36f484a53b8
spl set id: 16fc90ae-a919-4654-b635-d7b54923d448

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.