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 
Rite Aid Hdgrts Corp

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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2 to 12 YEARS
CHILDREN'S COLD & MUCUS DAY & NIGHT TIME

LOOSENS MUCUS IN CHEST, THROAT AND NOSE

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.

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

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

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.

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.

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.

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.

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.

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

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

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.

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.

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.

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. 

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.

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

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

cartonlabel

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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-2234
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-2234-11 in 1 CARTON; Type 0: Not a Combination Product12/29/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 118 mL
Part 21 BOTTLE 118 mL
Part 1 of 2
2 TO 12 YEARS CHILDRENS COLD AND MUCUS DAY TIME 
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 liquid
Product Information
Item Code (Source)NDC:11822-2245
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA3 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN3 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-2245-41 in 1 CARTON
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/29/2021
Part 2 of 2
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 liquid
Product Information
Item Code (Source)NDC:11822-1245
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1245-41 in 1 CARTON
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/29/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/29/2021
Labeler - Rite Aid Hdgrts Corp (014578892)
Registrant - Seaway Pharma Inc. (117218785)
Establishment
NameAddressID/FEIBusiness Operations
Bhargava Phytolab872292596manufacture(11822-2234, 11822-1245, 11822-2245)

Revised: 12/2021
Document Id: c6f7f8f9-61e7-4b93-8a01-27e4c13326ac
Set id: 16fc90ae-a919-4654-b635-d7b54923d448
Version: 1
Effective Time: 20211229
 
Rite Aid Hdgrts Corp