Label: CHILDRENS COLD AND COUGH DAY AND NIGHT VALUE PACK- onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal kit
- NDC Code(s): 0363-9996-01, 0363-9997-01, 0363-9998-01
- Packager: Walgreen Company
- 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 15, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Purpose
-
DAYTIME
Drug Facts
Active ingredients Purpose Allium Cepa 6X HPUS watery/runny nose, cold, hacking cough, sore 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” is the Homeopathic Pharmacopoeia of the United States.
Uses
Temporarily relieves the symptoms of the common cold including nasal or chest congestion, runny nose, sore throat, sneezing or cough.
Warnings
Consult a physician if
■ Symptoms persist for more than 7 days or worsen
■ Inflammation, fever or infection develops
■ Symptoms are accompanied by a fever
■ Cough tends to recur or is accompanied by a fever, rash or persistent headacheKeep 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 medical professional.Directions
■ Use as directed.
■ Do not refrigerate.
■ Shake well before using.
■ Measure only with the dosing cup provided.
■ Do not use dosing cup with other products.
■ On dosing cup, mL = milliliter.Children 2 years
to under 6 years
5 mL up to 6 times
per day (every 4 hours)
Children 6 years
to under 12 years
10 mL up to 6 times
per day (every 4 hours)
Adults and children
12 years and over
15 mL up to 6 times
per day (every 4 hours)
-
NIGHTTIME
Drug Facts
Active ingredients Purpose Allium Cepa 6X HPUS watery/runny nose, cold,
hacking cough, sore throatChamomilla 6X HPUS sensitive, irritable, fussy,
occasional sleeplessnessCoffea Cruda 6X HPUS occasional sleeplessness,
restlessnessHepar Sulph Calc 12X HPUS cold, sneezing Hydrastis 6X HPUS rattling/tickling cough,
sinus congestion, dry/raw/sore throatNatrum Muriaticum 6X HPUS dry cough, sore throat Phosphorus 12X HPUS hoarse/dry cough,
nasal congestion, chest congestionPulsatilla 6X HPUS moist cough, cold, nasal congestion Sulphur 12X HPUS chest congestion, nasal
congestion, sneezing, runny nose“HPUS” is the Homeopathic Pharmacopoeia of the United States.
Uses
Temporarily relieves the symptoms of the common cold including cough, runny nose, sneezing, nasal or chest congestion or sore throat with accompanying 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 fever
■ Cough tends to recur or is accompanied by a fever, rash or persistent headacheKeep 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 medical professional.Directions
■ Use as directed.
■ Do not refrigerate.
■ Shake well before using.
■ Measure only with the dosing cup provided.
■ Do not use dosing cup with other products.
■ On dosing cup, mL = milliliter.Children 2 years
to under 6 years
5 mL at bedtime and every
4 hours during the night
or as necessaryChildren 6 years
to under 12 years
10 mL at bedtime and every
4 hours during the night
or as necessary
Adults and children
12 years and over
15 mL at bedtime and every
4 hours during the night
or as necessary
- DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
- *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
- QUESTIONS
-
PRINCIPAL DISPLAY PANEL
DAY & NIGHT PACK NDC 0363-9998-01
Walgreens
Compare to Hyland's 4 Kids Cold &
Cough Day & Night Value Pack
WALGREENS PHARMACIST
RECOMMENDED
DAYTIME
Children's
Dye-Free
Cold &
Cough
Sugar Free
Alcohol Free
• Homeopathic
flavor free
4 FL OZ (118 mL) DAYTIME
NIGHTTIME
Children's
Dye-Free
Cold &
Cough
Sugar Free
Alcohol Free
• Homeopathic
flavor free
4 FL OZ (118 mL) NIGHTTIME
8 FL OZ (236 mL) TOTAL
AGES
2-12
YEARS
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
-
INGREDIENTS AND APPEARANCE
CHILDRENS COLD AND COUGH DAY AND NIGHT VALUE PACK
onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9998 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9998-01 1 in 1 CARTON; Type 0: Not a Combination Product 02/01/2019 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 CHILDRENS COLD AND COUGH
onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquidProduct Information Item Code (Source) NDC:0363-9997 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 1 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [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 WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9997-01 118 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 02/01/2019 Part 2 of 2 CHILDRENS COLD AND COUGH NIGHTTIME
onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal liquidProduct Information Item Code (Source) NDC:0363-9996 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X] in 1 mL MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 6 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9996-01 118 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 02/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/01/2019 Labeler - Walgreen Company (008965063)