Label: 4 KIDS COLD N COUGH GRAPE FLAVOR- onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquid
- NDC Code(s): 54973-3243-1, 54973-3243-2, 54973-3243-3, 54973-3243-4
- 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 September 18, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PURPOSE
-
Drug Facts
Active ingredients
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, post nasal drip Sulphur 12X HPUS chest congestion, nasal congestion, sneezing, runny nose "HPUS" is the Homeopathic Pharmacopœia of the United States.
- Uses*
-
Warnings
Sore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Ask a doctor before use if you have
■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).
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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 years5 mL up to 6 times per day
(every 4 hours).Children 6 years
to under 12 years10 mL up to 6 times per day
(every 4 hours).Adults and children
12 years and over15 mL up to 6 times per day
(every 4 hours). - Inactive ingredients
- Questions?
- *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
- DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
- Principal Display Panel - 4 FL. OZ. (118 mL)
- Principal Display Panel - 5 FL. OZ. (148 mL)
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INGREDIENTS AND APPEARANCE
4 KIDS COLD N 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:54973-3243 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 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 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) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color Score Shape Size Flavor GRAPE (Natural Grape Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3243-1 1 in 1 CARTON 02/10/2016 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:54973-3243-2 1 in 1 CARTON 02/10/2016 12/15/2021 2 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:54973-3243-3 5 mL in 1 POUCH; Type 0: Not a Combination Product 02/10/2016 12/15/2021 4 NDC:54973-3243-4 1 in 1 CARTON 02/10/2016 4 148 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 02/10/2016 Labeler - Hyland's Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 manufacture(54973-3243) , pack(54973-3243) , label(54973-3243)
