FDA Label for Umcka Fastactives Berry

View Indications, Usage & Precautions

Umcka Fastactives Berry Product Label

The following document was submitted to the FDA by the labeler of this product Schwabe North America, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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