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#
Contacts and useful links#
Label contents#
Full prescribing information#
DAYTIME
Drug Facts
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.
OTC - PURPOSE SECTION
LOOSENS MUCUS IN CHEST, THROAT AND NOSE
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.
Warnings
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)
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.
NIGHTTIME
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.
OTC - PURPOSE SECTION
LOOSENS MUCUS IN CHEST, THROAT AND NOSE
Uses
- 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)
Warnings
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
- 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
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
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
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11822-2234-1 | 2024-12-26 | C162847 | 48780-1 | 1030e365-37ac-111a-e063-dadaa90a10e2 | 2 to 12 YEARS CHILDREN'S COLD & MUCUS DAY & NIGHT TIME LOOSENS MUCUS IN CHEST, THROAT AND NOSE |
| 11822-2234-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-37ac-111a-e063-dadaa90a10e2 | 2 to 12 YEARS CHILDREN'S COLD & MUCUS DAY & NIGHT TIME LOOSENS MUCUS IN CHEST, THROAT AND NOSE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11822-1245-4 | 2 to 12 YEARS CHILDRENS COLD and MUCUS | 1 in 1 CARTON | LIQUID | 12 [hp_X] in 1mL | 2 | |
| 11822-1245-4 | 2 to 12 YEARS CHILDRENS COLD and MUCUS | 118 mL in 1 BOTTLE | LIQUID | 118 mL | 6 [hp_X] in 1mL | 2 |
| 11822-2234-1 | 2 to 12 YEARS CHILDRENS COLD and MUCUS | 1 in 1 CARTON | KIT | 1 | 2 | |
| 11822-2245-4 | 2 to 12 YEARS CHILDRENS COLD and MUCUS | 1 in 1 CARTON | LIQUID | 3 [hp_X] in 1mL | 2 | |
| 11822-2245-4 | 2 to 12 YEARS CHILDRENS COLD and MUCUS | 118 mL in 1 BOTTLE | LIQUID | 118 mL | 12 [hp_X] in 1mL | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11822-1245 | 2 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] | 2 | Unmatched | 20241228_16fc90ae-a919-4654-b635-d7b54923d448.zip |
| 11822-2234 | 2 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] | 2 | Legacy NDC, 5 package rows | 20241228_16fc90ae-a919-4654-b635-d7b54923d448.zip |
| 11822-2245 | 2 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] | 2 | Unmatched | 20241228_16fc90ae-a919-4654-b635-d7b54923d448.zip |
Products#
Every source-derived product name is available through these pages.
- 2 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
- 2 to 12 YEARS CHILDRENS COLD and MUCUS DAY TIME
- MATRICARIA CHAMOMILLA
- SODIUM CHLORIDE
- CHLORIDE ION
- SULFUR
- RUMEX CRISPUS ROOT
- GLYCYRRHIZA GLABRA
- SODIUM BENZOATE
- ONION
- BRYONIA ALBA ROOT
- EUPHRASIA STRICTA
- GOLDENSEAL
- PHOSPHORUS
- ARABICA COFFEE BEAN
- WATER
- CALCIUM SULFIDE
- SILICON DIOXIDE
- ANEMONE PULSATILLA
- CITRIC ACID MONOHYDRATE
- GLYCERIN
- 2 to 12 YEARS CHILDRENS COLD and MUCUS NIGHT TIME
- bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11822-2234 | 11822-2234-1 |
| 11822-1245 | 11822-1245-4 |
| 11822-2245 | 11822-2245-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 1307634d-2028-44e7-8eee-c36f484a53b8 | 16fc90ae-a919-4654-b635-d7b54923d448 | 2024-12-27 | Warnings | 1307634d-2028-44e7-8eee-c36f484a53b8 16fc90ae-a919-4654-b635-d7b54923d448 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
