WELLNESS WITH CHERRY FLAVOR COUGH SYRUP- althaea officinalis, prunus virginiana, inula helenium syrup

Wellness with Cherry Flavor by

Drug Labeling and Warnings

Wellness with Cherry Flavor by is a Homeopathic medication manufactured, distributed, or labeled by Source Naturals, ABCO Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

• Althaea officinalis 1x
• Prunus virginiana 1x
• Inula helenium 3x
• Marrubium vulgare 3x
  
• Eucalyptus globulus 6x
  
• Rumex crispus 6x
• Sanguinaria canadensis 6x
• Bryonia alba 12x
• Causticum 12x
• Nux vomica 12x
• Phosphorus 12x
• Pulsatilla nigricans 12x

PURPOSE

• Homeopathic cough syrup for kids and teens
  

KEEP OUT OF REACH OF CHILDREN

• Keep out of reach of children
  

INDICATIONS & USAGE

• For the temporary relief of coughs and congestion due to cold and flu.
  
• Helps loosen mucus (expectorant) and clear bronchial congestion.
• Soothes sore throat.

•         For best Results:

• • Keep mouth free of food and strong tastes for 15 minutes before and after taking.
• • Hold liquid in mouth for 10-15 seconds before swallowing.

WARNINGS

• In case of overdose get medical help or contact poison control center right away
• A persistent cough may be a sign of a serious condition
• If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a physician
• Do not give this product for persistent or chronic cough associate with smoking, asthma, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician
• As with any medicine, if you are pregnant, may become pregnant, or breasfeeding, seek the advice of a health care professional before using this product
  

DOSAGE & ADMINISTRATION

• Adults and children 12 years of age and older:   
  
• • Take 2 teaspoons every 4 hours
  • Or as needed
    

• Children 2 - 12 years of age:
• • Take 1 teaspoon every 4 hours  
  • Or as needed
    

• Children under 2: Consult a physician for use

INACTIVE INGREDIENT

Inactive Ingredients:

• Deionized water
• Fructose
• Natural Cherry flavor
• Vanilla flavor
• Natural color
• Citric acid
  
• Potassium Benzoate
• Xanthan gum
  

PRINCIPAL DISPLAY PANEL

• bottle image jpeg
  
• bottlelabel/.jpg
  

INGREDIENTS AND APPEARANCE

WELLNESS WITH CHERRY FLAVOR  COUGH SYRUP
althaea officinalis, prunus virginiana, inula helenium syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64471-185
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H) (ALTHAEA OFFICINALIS ROOT - UNII:TRW2FUF47H)	ALTHAEA OFFICINALIS ROOT	1 [hp_X]  in 118 mL
PRUNUS VIRGINIANA BARK (UNII: 477D3CRY10) (PRUNUS VIRGINIANA BARK - UNII:477D3CRY10)	PRUNUS VIRGINIANA BARK	1 [hp_X]  in 118 mL
INULA HELENIUM ROOT (UNII: E55SMD6DA8) (INULA HELENIUM ROOT - UNII:E55SMD6DA8)	INULA HELENIUM ROOT	3 [hp_X]  in 118 mL
MARRUBIUM VULGARE (UNII: 7A72MUN24Z) (MARRUBIUM VULGARE - UNII:7A72MUN24Z)	MARRUBIUM VULGARE	3 [hp_X]  in 118 mL
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6)	EUCALYPTUS GLOBULUS LEAF	6 [hp_X]  in 118 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C)	RUMEX CRISPUS ROOT	6 [hp_X]  in 118 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	6 [hp_X]  in 118 mL
BRYONIA ALBA WHOLE (UNII: 56K0VVT47P) (BRYONIA ALBA WHOLE - UNII:56K0VVT47P)	BRYONIA ALBA WHOLE	12 [hp_X]  in 118 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	12 [hp_X]  in 118 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	12 [hp_X]  in 118 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 118 mL
Anemone nemorosa (UNII: 9IH59MK596) (Anemone nemorosa - UNII:9IH59MK596)	Anemone nemorosa	12 [hp_X]  in 118 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
FRUCTOSE (UNII: 6YSS42VSEV)
CHERRY JUICE (UNII: 4XTQ10247Y)
VANILLA (UNII: Q74T35078H)
NATURAL RED 26 (UNII: P9ZT730WWS)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM BENZOATE (UNII: 763YQN2K7K)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64471-185-04	118 mL in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/16/2013

Labeler - Source Naturals (969024228)

Registrant - ABCO Laboratories, Inc. (029618279)

Establishment
Name	Address	ID/FEI	Business Operations
ABCO Laboratories, Inc.		029618279	manufacture(64471-185)