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  5. Label Information: Umcka Coldcare Day Plus Night

FDA Label for Umcka Coldcare Day Plus Night

View Indications, Usage & Precautions

Table of Contents

    1. WARNINGS
    2. ASK THE DOCTOR BEFORE USE IF YOU HAVE A
    3. STOP USE AND ASK THE DOCTOR
    4. WARNING IF PREGNANT OR BREAST FEEDING
    5. WARNING FOR CHILDREN
    6. OVERDOSE
    7. OTC ACTIVE INGREDIENTS:
    8. INACTIVE INGREDIENTS:
    9. DOSAGE AND ADMINISTRATION
    10. INDICATIONS AND USAGE
    11. OTC- PURPOSE
    12. UMCKA DAY PLUS NIGHT CARTON LABEL
    13. UMCKA COLDCARE DAY PACKET LABEL8 PACKETS PER CARTON
    14. 10601 UMCKA COLDCARE NIGHT4 PACKETS PER CARTON

Umcka Coldcare Day Plus Night 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.

Warnings



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

Consult a doctor promptly.

NIGHT: Sore Throat Warning: Severe or persistent sore throat for more than 2 days or if accompanied by high fever, headache, nausea or vomiting or rash may be serious.
Consult a doctor promptly.


Ask The Doctor Before Use If You Have A



DAY: Persistant or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysemaor is accompanied by excessive phlegm (mucus).

NIGHT: Persistant 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 The Doctor



DAY:  New symptoms occur, symptoms worsen do not get better within 7 days.

         Cough lasts more than 7 days or occurs with rash or presistent headache.

         Fever worsens or lasts more than 3 days.

         These could be signs of a serious condition

NIGHT:  New symptoms occur, symptoms worsen do not get better within 7 days.

        Cough lasts more than 7 days or occurs with rash or presistent headache.

        Fever worsens or lasts more than 3 days.

        These could be signs of a serious condition.


Warning If Pregnant Or Breast Feeding



DAY:   If pregnant or breastfeeding, ask a healthcare professional before use.

NIGHT:  If pregnant or breastfeeding, ask a healthcare professional before use.


Warning For Children



DAY:  Keep out of reach of children.

NIGHT:  Keep out of reach of children.


Overdose



DAY: In case of overdose, seek medical help or contact a Poison Control Center immediately.

NIGHT: In case of overdose, seek medical help or contact a Poison Control Center immediately.


Otc Active Ingredients:



DAY:  Pelargonium sidoides 1X

NIGHT: Pelargonium sidoides 1X

            Chamomilla recutila 2X

            Humulus Lupulus 1X

            Passiflora incarnate 1X


Inactive Ingredients:



DAY:  Citric acid, maltodextrin, natural flavor with other natural flavors, silica, turmeric (for color) xylitol.

NIGHT: Citric acid, honey, lactose monohydrate, lou han guo (Siraitia grosvenorii fruit), maltodextrin, natural flaveor with other natural flavors, silica, stevia leaf extract, turmeric (for color), xylitol.


Dosage And Administration



DAY:  Dissolve contents of one packet in 4-6 ounces of hot water and sip while hot.

May also be dissolved in 4-6 ounces of cold water, which may be preferable for children

For best results use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

ADULTS/CHILDREN 12 years of age and older:  Take 2 times daily

CHILDREN 6-11 years of age:   Take 1 - 2 times daily

CHILDREN UNDER 6:  consult a doctor

8 Packets per carton

NIGHT: Dissolve contents of one packet in 4-6 ounces of hot water and sip while hot.

May also be dissolved in 4-6 ounces of cold water, which may be preferable for children

For best results use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

ADULTS/CHILDREN 12 years of age and older: Take 1 packet 30 minutes prior to bedtime

CHILDREN 6-11 years of age: Take 1/2 packet 30 minutes prior to bedtime

CHILDREN UNDER 6: Consult a doctor

4 Packets per carton


Indications And Usage



DAY:  Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, headache, hoarseness, sore throat

Night: Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, headache, hoarseness, sore throat


Otc- Purpose



DAY:  Shortens duration and reduces severity of cough, congestion and sore throat.

NIGHT:  Shortens duration and reduces severity of cough, congestion, and sore throat.


Umcka Day Plus Night Carton Label



10601_UMCKA_CC_DAY_NIGHT_CTN_12


Umcka Coldcare Day Packet Label8 Packets Per Carton



10601_UMCKA_CC_DAY_02


10601 Umcka Coldcare Night4 Packets Per Carton



10601_UMCKA_CC_DAY_NIGHT_CTN_12


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