WELLNESS4COUGH SYRUP COUGH SYRUP- althaea officinalis, prunus virginiana, inula helenium syrup

Wellness4Cough Syrup by

Drug Labeling and Warnings

Wellness4Cough Syrup 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

Wellness4

bottle label image

INGREDIENTS AND APPEARANCE

WELLNESS4COUGH SYRUP   COUGH SYRUP
althaea officinalis, prunus virginiana, inula helenium syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64471-330
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
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	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: 64471-330-04	118 mL in 1 BOTTLE, PLASTIC

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(64471-330)