NDC | 64471-330-04 |
Set ID | da1463c8-8805-4fbc-88f2-210caead8ea3 |
Category | HUMAN OTC DRUG LABEL |
Packager | Source Naturals |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- ACTIVE INGREDIENT
- PURPOSE
- 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.
- For the temporary relief of coughs and congestion due to cold and flu.
-
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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
WELLNESS4COUGH SYRUP COUGH SYRUP
althaea officinalis, prunus virginiana, inula helenium syrupProduct 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)