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 
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 & COUGH DAY & NIGHT TIME

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

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses

  • temporarily relieves the symptoms of common cold including nasal and chest congestion, runny nose, sore throat, sneezing and cough.

Warnings

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

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 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

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

HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

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

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

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 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.

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

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

Distributed by:

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

PACKAGE LABEL - KIT CARTON

CHILDREN'S COLD & COUGH 

Sugar Free, Dye Free

Alcohol free

DAYTIME

Cough
Nasal Congestion
Runny Nose
Sore Throat
Sneezing

NIGHTTIME

Cough
Sneezing
Runny Nose
Sleeplessness
Sore Throat

2-12 YEARS

TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)

HOMEOPATHIC

catronlabel

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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-2233
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-2233-11 in 1 CARTON; Type 0: Not a Combination Product12/28/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 118 mL
Part 21 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 liquid
Product Information
Item Code (Source)NDC:11822-1246
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
water (UNII: 059QF0KO0R)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1246-41 in 1 CARTON
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/28/2021
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 liquid
Product Information
Item Code (Source)NDC:11822-2246
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-2246-41 in 1 CARTON
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/28/2021
Labeler - Rite Aid Hdgrts Corp (014578892)
Registrant - Seaway Pharma Inc. (117218785)
Establishment
NameAddressID/FEIBusiness Operations
Bhargava Phytolab872292596manufacture(11822-2233, 11822-1246, 11822-2246)

Revised: 1/2022
Document Id: e5e31f79-de40-43fd-a3cb-275e917f4fd0
Set id: 75ad8ebf-c8f2-4f9b-802b-fe63fc985ede
Version: 1
Effective Time: 20220105
 
Rite Aid Hdgrts Corp