NDC | 63388-915-14, 63388-915-15, 63388-915-19 |
Set ID | de020891-eca2-405c-81cd-75dfb4ffe586 |
Category | HUMAN OTC DRUG LABEL |
Packager | Laboratoire Atlas Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- ACTIVE INGREDIENT
-
PURPOSE
Purpose
Drosera 1C...........................dry cough
Arnica Montana 3C.................aches and pains, chest congestion
Bryonia 3C............................painful cough
Cetraria islandica 3C...............cough with expectoration
Coccus cacti 3C......................cough with expectoration
Corallium rubrum 3C...............painful cough
Stannum metallicum 3C...........cough, chills and lessens mucus
Chamomilla 4C.......................restlessness, irritability, nocturnal awakenings
Coffee crudea 4C....................restlessness and sleeplessness
The letters "HPUS" indicate that the components in this product are officially
monographed in the Homeopathic Pharmacopoeia of the United States
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Stop use and ask a doctor if •pain or cough gets worse or lasts
more than 5 days ( children) or 7 days (adults) •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.
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
KIDS RELIEF
drosera, arnica montana, bryonia, cetraria islandica, coccus cacti, corallium rubrum, stannum metallicum, chamomilla, coffee crudea liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63388-915 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 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 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63388-915-15 1 in 1 CARTON 03/03/2018 1 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:63388-915-19 1 in 1 CARTON 03/03/2018 2 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:63388-915-14 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) Establishment Name Address ID/FEI Business Operations Laboratoire Atlas Inc 247880834 manufacture(63388-915)