NDC | 63388-918-54, 63388-918-55, 63388-918-59 |
Set ID | dd9a33c7-2d6a-434f-acf4-0cdad467537d |
Category | HUMAN OTC DRUG LABEL |
Packager | Laboratoire Atlas Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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ACTIVE INGREDIENT
Active Ingredients HPUS:
Drosera 1C (Sundew)
Arnica montana 3C (Leopard's Bane)
Bryonia 3C (White Bryony)
Ipecacuanha 3C (Ipecac)
Cetraria islandica 1C (Iceland Moss)
Coccus cacti 3C (Cochineal)
Corallium rubrum 3C (Red Coral)
Stannum metallicum 3C (Tin)
The letters "HPUS" indicate that the components in this product are officially
monographed in the Homeopathic Pharmacopoeia of the United States
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PURPOSE
Purpose
Drosera 1C (Sundew)...............................................dry cough
Arnica montana 3C (Leopard's Bane)..........................aches and pains, chest congestion
Bryonia 3C (White Bryony).......................................painful cough
Ipecacuanha 3C (Ipecac).........................................dry cough
Cetraria islandica 1C (Iceland Moss)..........................cough with expectoration
Coccus cacti 3C (Cochineal).....................................cough with expectoration
Corallium rubrum 3C (Red Coral)..............................painful cough
Stannum metallicum 3C (Tin)..................................coughs, chills and lessens mucus
- INDICATIONS & USAGE
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WARNINGS
Warnings: Stop use and ask a doctor if: •Pain & cough get
worse or last more than 5 days. •Fever gets worse or lasts more
than 3 days •Redness or swelling is present •New symptoms
occur •Cough comes back or occurs with a rash or headache that
lasts. These could be signs of a serious condition.
If you are pregnant or breast-feeding, ask a health professional
before use.
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions: •Do not exceed recommended dosage. •Do not take with
food •Repeat every 4 hours and reduce with improvement or as directed
by a health professional.
Age................................................................Dose
Adults and children 12+ years...........................10 ml or 2 teaspoons (tsp)
Children 6 to 11 years of age.............................5 ml or 1 teaspoon (tsp)
Children 2 to 5 years of age...............................2.5 ml or 1/2 teaspoon (tsp)
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REAL RELIEF
drosera, bryonia, ipecacuanha, cetraria islandica, coccus cacti, corallium rubrum, stannum metallicum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63388-918 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG) DROSERA ROTUNDIFOLIA FLOWERING TOP 1 [hp_C] in 100 mL ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 3 [hp_C] in 100 mL BRYONIA ALBA WHOLE (UNII: 56K0VVT47P) (BRYONIA ALBA WHOLE - UNII:56K0VVT47P) BRYONIA ALBA WHOLE 3 [hp_C] in 100 mL IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 3 [hp_C] in 100 mL CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1) (CETRARIA ISLANDICA SUBSP. ISLANDICA - UNII:BJ7YPN79A1) CETRARIA ISLANDICA SUBSP. ISLANDICA 1 [hp_C] in 100 mL PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI 3 [hp_C] in 100 mL CORALLIUM RUBRUM WHOLE (UNII: 22Z32PWR7R) (CORALLIUM RUBRUM WHOLE - UNII:22Z32PWR7R) CORALLIUM RUBRUM WHOLE 3 [hp_C] in 100 mL TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN 3 [hp_C] in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) CARAMEL (UNII: T9D99G2B1R) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63388-918-55 1 in 1 CARTON 03/03/2018 1 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:63388-918-59 1 in 1 CARTON 03/03/2018 2 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:63388-918-54 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/03/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/03/2018 Labeler - Laboratoire Atlas Inc (247880834) Registrant - Laboratoire Atlas Inc (247880834)