Umcka Fastactives Berry Powder
FDA Label NDC 53499-9349

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Schwabe North America, Inc for the product Umcka Fastactives Berry (NDC 53499-9349). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, dosage & administration, indications & usage, otc - purpose, warnings, otc - keep out of reach of children, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient:

PELARGONIUM SIDOIDES 1X

ACONITUM NAPELLUS  4X

EUCALYPTUS GLOBULUS 2X

BRYONIA 4X

EUPATORIUM PERFOLIATUM  6X

GELSEMIUM SEMPERVIRENS 4X

IPECACUANHA 3X

PHOSPHORUS 6X

Inactive Ingredient

Inactive Ingredients:

CITRIC ACID
LACTOSE MONOHYDRATE
MALIC ACID
MALTODEXTRIN
NATURAL BERRY FLAVORS
SILICA
XYLITOL

Dosage & Administration

Dosage and Administration:

Nature's Way Brand:

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 and children 12 years of age and older: take contents of 1 packet 4-5 times daily.
Children 6-11 years of age: take contents of 1 packet 2-4 times daily.
Children under 6 years of age: consult a physician.

Indications & Usage

Indications and Usage:

Shortens duration and reduces severity of symptoms associated with the common cold and throat/sinus/bronchial infections, and temporarily relieves flu symptoms: chills/fever, congestion/stuffy nose, cough, headache, hoarseness, minor aches/pains, sneezing/runny nose, and sore throat. 

Otc - Purpose

Purpose:

Shortens duration and reduces severity of symptoms associated with the common cold and throat/sinus/bronchial infections, and temporarily relieves flu symptoms: chills/fever, congestion/stuffy nose, cough, headache, hoarseness, minor aches/pains, sneezing/runny nose, and sore throat. 

Warnings

Warnings:

Sore throat warning:  Severe or persistent sore throat for more than 2 days of if accompanied by high fever, headache, nausea, vomiting, or rash may be serious.

Consult a physician promptly.

Otc - Keep Out Of Reach Of Children

Keep Out of Reach of Children:

Keep out of the reach of children.

Otc - Ask Doctor

Ask the Doctor:

Ask a doctor before use if you have a persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema or is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 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.

Otc - Pregnancy Or Breast Feeding

Pregnancy or Breast Feeding:

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

Packaging Label. Principal Display Panel:Natures Way 15349_Umcka Fastactive Berry_A02 10 Packets/Carton

15349_UMCKA FASTACTIVE BERRY_A02

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