Label: CHILDRENS COLD AND COUGH GRAPE FLAVOR- onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquid
- NDC Code(s): 0363-9999-01
- 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 21, 2021
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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Drug Facts
Active ingredients
Allium Cepa 6X HPUS
Hepar Sulph Calc 12X HPUS
Hydrastis 6X HPUS
Natrum Muriaticum 6X HPUS
Phosphorus 12X HPUS
Pulsatilla 6X HPUS
Sulphur 12X HPUS
“HPUS” indicates that the active ingredients are in the
official Homeopathic Pharmacopœia of the United States.
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
-
Warnings
Consult a physician if
- symptoms persist for more than 7 days or worsen.
- inflammation, fever or infection develops.
- 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.
Keep 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 health care professional.
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Drug Facts (continued)
Directions
- 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)
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Questions or comments?
- PRINCIPAL DISPLAY PANEL-4 FL OZ (118 mL) Bottle Carton
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INGREDIENTS AND APPEARANCE
CHILDRENS COLD AND COUGH GRAPE FLAVOR
onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9999 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 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 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9999-01 1 in 1 CARTON 12/14/2018 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 12/14/2018 Labeler - Walgreen Company (008965063) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(0363-9999) Establishment Name Address ID/FEI Business Operations LGM Pharma Solutions, LLC 117549198 manufacture(0363-9999) , pack(0363-9999) , label(0363-9999) Establishment Name Address ID/FEI Business Operations Applied Laboratories, Inc. 876754375 manufacture(0363-9999) , pack(0363-9999) , label(0363-9999)
