Label: COLD RELIEF ALCOHOL FREE CHERRY SYRUP- pelargonium sidoides syrup
- NDC Code(s): 53499-4463-4
- Packager: Schwabe North America, 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 October 29, 2024
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- Active Ingredient
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Dosage & Administration:
For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.
Shake well before each use.
Use only with enclosed dosage cup.
Adults and children 13 years of age and older: Take 1½ teaspoon (tsp) (7.5mL) three times daily.
Children 6-12 years of age: Take 1 teaspoon (5mL) three times daily.
Children 1-5 years of age: Take ½ teaspoon (2.5 mL) three times daily. -
Warnings
Sore throat warning: If sore throat is severe, persistes more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Ask Doctor
Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family.
Individuals with allergies to plants of the Geraniaceae family should use this product with caution.
Stop Use
Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.
These could be signs of a serious condition.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COLD RELIEF ALCOHOL FREE CHERRY SYRUP
pelargonium sidoides syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-4463 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT 1 [hp_X] in 120 mL Inactive Ingredients Ingredient Name Strength ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ALCOHOL (UNII: 3K9958V90M) FRUCTOSE (UNII: 6YSS42VSEV) MALTODEXTRIN (UNII: 7CVR7L4A2D) WATER (UNII: 059QF0KO0R) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color Score Shape Size Flavor CHERRY (NATURAL CHERRY FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53499-4463-4 3 in 1 CARTON 05/22/2023 06/30/2025 1 120 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 05/22/2023 06/30/2025 Labeler - Schwabe North America, Inc (831153908) Establishment Name Address ID/FEI Business Operations Schwabe North America, Inc 831153908 manufacture(53499-4463) Establishment Name Address ID/FEI Business Operations ProSolutions, Inc. 070769782 label(53499-4463) , pack(53499-4463)
