COLD FLU RELIEF BERRY powder

Cold Flu Relief Berry by

Drug Labeling and Warnings

Cold Flu Relief Berry by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc, ProSolutions, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Pelargonium sidoides 1X

Aconium napellus 4X

Eucalyptus globulus 2X

Bryonia 4X

Eupatorium perfoliatum 6X

Gelsemium sempervirens 4X

Phosphorus 6X

Ipecacuanha 3X

Inactive Ingredients

Citric Acid

Lactose Monohydrate

Malic Acid

Maltodextrin

Natural Flavor

Silica

Xylitol

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. 

Purpose

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

Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or following 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 emphysemsa, a cough that is accompanied by excessitve phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family. 

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. 

Pregnancy or breast feeding

If pregnant or breast-feeding, ask a healthcare professional before use. 

Keep out of reach of children

Keep out of reach of children.

Overdose

In case of overdose, seek medical help or contact a Posion Control Center right away. 

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

COLD FLU RELIEF BERRY 
cold flu relief berry powder

Product 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)