Label: COLD FLU RELIEF BERRY powder
- NDC Code(s): 53499-0349-0
- 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 June 21, 2024
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- Active Ingredients
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Dosage & Administration
Directions
Tear packet open, pour contents into mouth and swallow. For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.
Adults & children 13 years of age and older: take contents of 1 packet three times daily.
Children 6-12 years of age: take contents of 1 packet two times daily.
Children under 6 years of age: consult a doctor.Indications & Usage
Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations, and temporarily relieves flu symptoms: chills/fever, chest congestion, nasal congestion, cough, headache, hoarseness, body aches, sneezing/runny nose, sore throat.
- Warnings
- 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 FLU RELIEF BERRY
cold flu relief berry powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-0349 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 912 mg ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 4 [hp_X] in 912 mg EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF 2 [hp_X] in 912 mg BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 4 [hp_X] in 912 mg EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X] in 912 mg GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 4 [hp_X] in 912 mg PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 6 [hp_X] in 912 mg IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 3 [hp_X] in 912 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MALIC ACID (UNII: 817L1N4CKP) MALTODEXTRIN (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color Score Shape Size Flavor BERRY (NATURAL BERRY FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53499-0349-0 10 in 1 CARTON 06/21/2024 1 912 mg in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/21/2024 Labeler - Schwabe North America, Inc (831153908) Establishment Name Address ID/FEI Business Operations Schwabe North America, Inc 831153908 manufacture(53499-0349) Establishment Name Address ID/FEI Business Operations ProSolutions, Inc. 070769782 label(53499-0349) , pack(53499-0349)