Label: 2 TO 12 YEARS CHILDRENS COLD AND COUGH DAY AND NIGHT TIME- onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean kit
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- NDC Code(s): 11822-1246-4, 11822-2233-1, 11822-2246-4
- 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 January 5, 2022
If you are a consumer or patient please visit this version.
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DAYTIME
Drug Facts
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.
Warnings
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.
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
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.
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 years1 teaspoon or 5 mL up to 6 times per day (every 4 hours) Children 6 years
to under 12 years2 teaspoons or 10 mL up to 6 times per day (every 4 hours) Adults and children
12 years and over3 teaspoons or 15 mL up to 6 times per day (every 4 hours)
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NIGHTTIME
Drug Facts
Active ingredients
Purpose
Allium Cepa 6X HPUS
watery/runny nose, cold, hacking cough, painful throat
Chamomilla 6X HPUS
sensitive, irritable, fussy, nocturnal occasional sleeplessness
Coffea Cruda 6X HPUS
occasional sleeplessness, restlessness
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 the common cold including cough, runny nose, sneezing, nasal and chest congestion, and sore throat with accompanying occasional sleeplessness.
Warnings
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
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.
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 years1 teaspoon or 5 mL up to 6 times per day (every 4 hours) Children 6 years
to under 12 years2 teaspoons or 10 mL up to 6 times per day (every 4 hours) Adults and children
12 years and over3 teaspoons or 15 mL up to 6 times per day (every 4 hours)
- SPL UNCLASSIFIED SECTION
- OTHER SAFETY INFORMATION
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL - KIT CARTON
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INGREDIENTS AND APPEARANCE
2 TO 12 YEARS CHILDRENS COLD AND COUGH DAY AND NIGHT TIME
onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-2233 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-2233-1 1 in 1 CARTON; Type 0: Not a Combination Product 12/28/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 118 mL Part 2 1 BOTTLE, PLASTIC 118 mL Part 1 of 2 2 TO 12 YEARS CHILDRENS COLD AND COUGH DAY TIME
onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean liquidProduct Information Item Code (Source) NDC:11822-1246 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) water (UNII: 059QF0KO0R) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-1246-4 1 in 1 CARTON 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/28/2021 Part 2 of 2 2 TO 12 YEARS CHILDRENS COLD AND COUGH NIGHT TIME
onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean liquidProduct Information Item Code (Source) NDC:11822-2246 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X] in 1 mL MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 6 [hp_X] in 1 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 6 [hp_X] in 1 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-2246-4 1 in 1 CARTON 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/28/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/28/2021 Labeler - Rite Aid Hdgrts Corp (014578892) Registrant - Seaway Pharma Inc. (117218785) Establishment Name Address ID/FEI Business Operations Bhargava Phytolab 872292596 manufacture(11822-2233, 11822-1246, 11822-2246)
