NDC | 63388-989-49 |
Set ID | fe18547a-0212-4cdf-accd-566ef122ff27 |
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 (Leopards Bane)
Bryonia 3C (Whte Bryony)
Ipecacuanha 3C (Ipecac)
Cetraria islandica 1C (Iceland Moss)
Coccus cacti 3C (Cochineal)
Corallium rubrum 3C (Red Coral)
Stannum metallicum 3C (Tin)
Camomilla 4C (German Chamomille)
Coffea crudea 4C (coffee)
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PURPOSE
Purpose
Drosera 1C......................................dry cough
Arnica montana 3C...........................aches and pains, chest congestion
Bryonia 3C......................................painful cough
Ipecacuanha 3C...............................night cough
Cetraria islandica 1C.........................cough with expectoration
Coccus cacti 3C................................cough with expectoration
Corallium rubrum 3C.........................painful cough
Stannum metallicum 3C.....................cough, chills, and lessens mucus
Camomilla 4C...................................restlessness, irritability, nocturnal awakenings
Coffea crudea 4C..............................restlessness and sleeplessness
The letters "HPUS" indicate that the components in this product are officially
monographed in the Homeopathic Pharcopoeia of the United States
- INDICATIONS & USAGE
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WARNINGS
Warnings
Stop use and ask a doctor if •Pain & cough gets worse
or lasts 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 rash or headache that lasts.
These could be signs of a serious condition
If you are pregnant or breastfeeding, 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 •Take before bedtime. Repeat every 8 hours as needed and reduce
with improvement or as directed by a health care 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
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INGREDIENTS AND APPEARANCE
REAL RELIEF
drosera, arnica montana, bryonia, ipecacuanha, cetraria islandica, coccus cacti, corallium rubrum, stannum metallicum, camomilla, coffea crudea liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63388-989 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 CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 4 [hp_C] in 100 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 4 [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) Product Characteristics Color Score Shape Size Flavor grape Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63388-989-49 1 in 1 CARTON 05/03/2018 1 250 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/03/2018 Labeler - Laboratoire Atlas Inc (247880834) Registrant - Laboratoire Atlas Inc (247880834) Establishment Name Address ID/FEI Business Operations Laboratoire Atlas Inc 247880834 manufacture(63388-989)