NDC | 53499-3194-2 |
Set ID | da7af566-d869-40e2-b88b-7e4a5cf5c080 |
Category | HUMAN OTC DRUG LABEL |
Packager | Schwabe North American, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- Active Ingredient
- Inactive Ingredient
-
Purpose
Shortens duration and reduces severity of symptoms associated with the common cold and throat, nasal, bronchial irritations and temporarily relieves allergy and sinus symptoms; cough, congestion, promotes sinus drainage, helps decongest sinus openings and passages, headache, sneezing/runny nose, burning, itchy eyes, sore throat, shrinks swollen nasal membranes, sinus presssure.
-
Indications and Usage Section
Shortens duration and reduces severity of symptoms associated with the common cold and throat, nasal, bronchial irritations and temporarily relieves allergy and sinus symptoms; cough, congestion, promotes sinus drainage, helps decongest sinus openings and passages, headache, sneezing/runny nose, burning, itchy eyes, sore throat, shrinks swollen nasal membranes, sinus presssure.
-
Dosage & Administration
Chew or dissolve tablets in 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 occur.
Adults & Children 12 years of age and older: Take 1 chewable tablet 3 times daily.
Children 6-11 of age: Take 1 chewable tablet times daily.
Children under 6 years of age: Consult a physician
- Warnings
- Ask a Doctor Section
- Stop Use
- Pregnancy or Breast Feeding
- Keep out of reach of children
- Overdose
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
UMCKA ALLERGY AND SINUS
pelargonium sidoides root, hydrastis canadensis whole, potassium chloride, sanguinaria canadensis root, pulsatilla vulgaris, silicon dioxide tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-3194 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] HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T) (HYDRASTIS CANADENSIS WHOLE - UNII:R763EBH88T) HYDRASTIS CANADENSIS WHOLE 6 [hp_X] POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 3 [hp_X] SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT 6 [hp_X] PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS 6 [hp_X] SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 6 [hp_X] Inactive Ingredients Ingredient Name Strength CHERRY (UNII: BUC5I9595W) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) 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 white Score no score Shape ROUND Size 16mm Flavor CHERRY Imprint Code C Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53499-3194-2 2 in 1 CARTON 06/01/2018 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 06/01/2018 Labeler - Schwabe North American, Inc. (831153908) Establishment Name Address ID/FEI Business Operations Schwabe North America, Inc. 831153908 manufacture(53499-3194)