NDC | 53499-2347-0 |
Set ID | c761598b-9f78-471a-83a3-8a391841e948 |
Category | HUMAN OTC DRUG LABEL |
Packager | Schwabe North America, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- Active Ingredient
- Inactive Ingredients
-
Dosage and Administration
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 12 years of age and older: Take 1 chewable tablet 3 times daily.
Children 6-11 years of age: Take 1 chewable tablet 2 times daily.
Children under 6 years of age: consult a physician. - Indications & Usage
- Purpose
- Warning
- Ask Doctor
- Stop Use
- Pregnancy or breast feeding
- Keep out of reach of children.
- Overdose
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
UMCKA COLD FLU BERRY CHEWABLE
pelargonium sidoides, aconitum napellus, bryonia, eucalyptus globulus, eupatorium perfoliatum, gelsemium sempervirens, ipecacuanha, phosphorus tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-2347 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] ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 4 [hp_X] BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 4 [hp_X] EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF 2 [hp_X] EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X] GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 4 [hp_X] IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 3 [hp_X] PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 6 [hp_X] Inactive Ingredients Ingredient Name Strength ANNATTO (UNII: 6PQP1V1B6O) BEET JUICE (UNII: IOZ32L9H3O) CARAMEL (UNII: T9D99G2B1R) 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 pink (pink with pinkish-purple specks) Score no score Shape ROUND (C) Size 16mm Flavor BERRY (NATURAL BERRY FLAVOR) Imprint Code C Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53499-2347-0 1 in 1 CARTON 08/27/2018 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 08/27/2018 Labeler - Schwabe North America, Inc. (831153908) Establishment Name Address ID/FEI Business Operations Schwabe North America, Inc 831153908 manufacture(53499-2347)