Label: COLD RELIEF CHERRY- pelargonium sidoides tablet, chewable
- NDC Code(s): 53499-6144-0
- 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 13, 2023
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- Active Ingredient
- Inactive Ingredient
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Dosage & Adminstration
Chew or dissolve tablets in the mouth; do not swallow whole
For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease
Adults and children 13 years of age and older: take 1 chewable tablet three times daily
Children 6-12 years of age: take 1 chewable tablet two times daily
Children under 6 years of age: consult a doctor - Indications & Usage
- Purpose
- Warning
- Ask a doctor
- Stop use
- Pregnancy or Breast feeding
- Keep out of reach of children
- Overdose
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COLD RELIEF CHERRY
pelargonium sidoides tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-6144 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] Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) MAGNESIUM STEARATE (UNII: 70097M6I30) MALIC ACID (UNII: 817L1N4CKP) MALTODEXTRIN (UNII: 7CVR7L4A2D) MANNITOL (UNII: 3OWL53L36A) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SORBITOL (UNII: 506T60A25R) STEARIC ACID (UNII: 4ELV7Z65AP) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color pink (CHERRY TABLET) Score no score Shape ROUND (C) Size 16mm Flavor CHERRY (NATURAL CHERRY FLAVOR) Imprint Code C Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53499-6144-0 2 in 1 CARTON 09/05/2023 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/05/2023 Labeler - Schwabe North America, Inc (831153908) Establishment Name Address ID/FEI Business Operations Schwabe North America, Inc. 831153908 manufacture(53499-6144)