Label: 4 KIDS COLD AND COUGH DAYTIME- onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid
- NDC Code(s): 54973-3400-1
- Packager: Hyland's Inc.
- Category: HUMAN OTC DRUG LABEL
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 November 18, 2022
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- Official Label (Printer Friendly)
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Drugs 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.
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
Uses
Temporarily relieves the symptoms of the common cold including: nasal or chest congestion, runny nose, sore throat, sneezing, cough.
Warnings
Consult a physician if
- Symptoms persist for more than 7 days or worsen
- Inflammation, fever or infection develops
- Symptoms are accompanied by high fever (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 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.
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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, tsp = teaspoon
Children 2 years to
under 6 years
5 mL or 1 teaspoon up to 6
times per day (every 4 hours)
Children 6 years to
under 12 years
10 mL or 2 teaspoons up to 6
times per day (every 4 hours)
Adults and children
12 years and over
15 mL or 3 teaspoons up to 6
times per day (every 4 hours)
- Principal Display Panel - 148 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
4 KIDS COLD AND COUGH DAYTIME
onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3400 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 CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [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 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 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3400-1 1 in 1 CARTON 08/01/2008 1 148 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 08/01/2008 Labeler - Hyland's Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 manufacture(54973-3400) , pack(54973-3400) , label(54973-3400) Establishment Name Address ID/FEI Business Operations LGM Pharma Solutions, LLC 117549198 manufacture(54973-3400) , pack(54973-3400) , label(54973-3400) Establishment Name Address ID/FEI Business Operations Applied Laboratories, Inc. 117337220 manufacture(54973-3400) , pack(54973-3400) , label(54973-3400)
