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

2 to 12 YEARS CHILDRENS COLD and COUGH DAY and NIGHT TIME by

Drug Labeling and Warnings

2 to 12 YEARS CHILDRENS COLD and COUGH DAY and NIGHT TIME by is a Homeopathic medication manufactured, distributed, or labeled by Rite Aid Hdgrts Corp, Seaway Pharma Inc., Bhargava Phytolab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

SPL UNCLASSIFIED SECTION

THIS INFORMATION IS BASED UPON TRADITIONAL HOMEOPATHIC PRACTICE. THESE HAVE NOT BEEN REVIEWED BY FOOD AND DRUG ADMINISTRATION

OTHER SAFETY INFORMATION

TAMPER-EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND OR SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

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

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 kit

Product 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 liquid

Product 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 liquid

Product 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)