Label: CHILDRENS COLD AND COUGH DAY AND NIGHT TWIN PACK- onion,matricaria chamomilla,arabica coffee bean,calcium sulfide,goldenseal,sodium chloride,phosphorus,anemone pulsatilla and sulfur kit
- NDC Code(s): 49035-920-01, 49035-925-01, 49035-927-01
- Packager: Wal-Mart Stores, Inc
- 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)
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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” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
- Uses
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Warnings
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
- Drug Facts (continued)
- Other information
- Inactive ingredients
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NIGHTTIME
Drug Facts
Active ingredients Purpose Allium Cepa 6X HPUS watery/runny nose, cold, hacking cough, sore 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 Pharmacopœia of the United States.
- Uses
- Warnings
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Drug Facts (continued)
- 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
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
- 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 5mL at bedtime and every 4 hours during the night or as necessary
Children 6 years to under 12 years 10mL at bedtime and every 4 hours during the night or as necessary Adults and children 12 years and over 15mL at bedtime and every 4 hours during the night or as necessary - Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
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Primary Principal Display Panel - Children's Cold & Cough Day & Night Value Pack
VALUE PACK
NDC 49035-95-01
Equate™
Compare to
Hyland’s 4 Kids
Cold ‘n Cough Day
& Night Value Pack
active ingredients
Children's
Alcohol-Free, Sugar-Free Dye-Free
Homeopathic
Cold & Cough*
Daytime
Ages 2 to12 years
For Temporary Relief of:
- Nasal congestion
- Runny nose
- Sore throat
- Sneezing
- Cough
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
4 FL OZ (118mL) Daytime
8 FL OZ (236mL) TOTAL
Children's
Alcohol-Free, Sugar-Free Dye-Free
Homeopathic
Cold & Cough*
Nighttime
Ages 2 to12 years
For Temporary Relief of:
- Chest congestion
- Occasional sleeplessness
- Runny nose
- Sore throat
- Sneezing
- Cough
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
4 FL OZ (118mL) Nighttime
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INGREDIENTS AND APPEARANCE
CHILDRENS COLD AND COUGH DAY AND NIGHT TWIN PACK
onion,matricaria chamomilla,arabica coffee bean,calcium sulfide,goldenseal,sodium chloride,phosphorus,anemone pulsatilla and sulfur kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-925 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-925-01 1 in 1 CARTON; Type 0: Not a Combination Product 07/01/2018 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 NIGHTTIME COLD AND COUGH
onion, arabica coffee bean, calcium sulfide, phosphorus, matricaria chamomilla, anemone pulsatilla, goldenseal, sulfur and sodium chloride liquidProduct Information Item Code (Source) NDC:49035-920 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 ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 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 ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6 [hp_X] in 1 mL MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 6 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-920-01 118 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 07/02/2018 Part 2 of 2 COLD AND COUGH
onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquidProduct Information Item Code (Source) NDC:49035-927 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [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 Inactive Ingredients Ingredient Name Strength GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-927-01 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 06/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/01/2018 Labeler - Wal-Mart Stores, Inc (051957769)