Label: 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
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Contains inactivated NDC Code(s)
NDC Code(s): 11822-1245-4, 11822-2234-1, 11822-2245-4 - Packager: Rite Aid Hdgrts Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated December 29, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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.
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
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.
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)
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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.
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
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.
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)
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INGREDIENTS AND APPEARANCE
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 kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-2234 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-2234-1 1 in 1 CARTON; Type 0: Not a Combination Product 12/29/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 118 mL Part 2 1 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 liquidProduct Information Item Code (Source) NDC:11822-2245 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 3 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mL RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT 6 [hp_X] in 1 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] in 1 mL EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 30 [hp_X] in 1 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 3 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 12 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-2245-4 1 in 1 CARTON 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/29/2021 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 liquidProduct Information Item Code (Source) NDC:11822-1245 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 30 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 30 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 12 [hp_X] in 1 mL RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT 6 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-1245-4 1 in 1 CARTON 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/29/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/29/2021 Labeler - Rite Aid Hdgrts Corp (014578892) Registrant - Seaway Pharma Inc. (117218785) Establishment Name Address ID/FEI Business Operations Bhargava Phytolab 872292596 manufacture(11822-2234, 11822-1245, 11822-2245)
