Label: COUGH SYRUP (camphor- natural, arsenic trioxide, bryonia alba root, drosera rotundifolia, ipecac, potassium carbonate, phosphorus, anemone pulsatilla, spongia officinalis skeleton, roasted, drimia maritima whole syrup
- NDC Code(s): 43406-0664-4
- Packager: Natural Creations, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated December 19, 2022
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- PURPOSE
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
WARNINGS:
- Consult a physician for use in children under 12 years of age.
- IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
- KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
- Do not use if TAMPER EVIDENT seal is broken or missing.
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: Acacia Gum, Anise Oil, Citric Acid, Eucalyptus Oil, Glycerin, Herbal Base [Chamomile (flower), Echinacea Angustifolia (Flower), Iceland Moss (Herb), Marshmallow (Root), Mullein (Leaf), Plantain (Leaf), Red Clover (Flower), Stinging Nettle (Leaf), Thyme (Herb)], Honey, Natural Cherry Flavor, Natural Mixed Berry Flavor, Potassium Sorbate, Purified Water.
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INGREDIENTS AND APPEARANCE
COUGH SYRUP
camphor (natural), arsenic trioxide, bryonia alba root, drosera rotundifolia, ipecac, potassium carbonate, phosphorus, anemone pulsatilla, spongia officinalis skeleton, roasted, drimia maritima whole syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43406-0664 Route of Administration oral Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 30 [hp_C] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 30 [hp_C] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 30 [hp_C] in 1 mL DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA 30 [hp_C] in 1 mL IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 30 [hp_C] in 1 mL POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE 30 [hp_C] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 30 [hp_C] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 30 [hp_C] in 1 mL SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 30 [hp_C] in 1 mL DRIMIA MARITIMA WHOLE (UNII: UNM4C1735Z) (DRIMIA MARITIMA WHOLE - UNII:UNM4C1735Z) DRIMIA MARITIMA WHOLE 30 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) ANISE OIL (UNII: 6Y89129C8H) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EUCALYPTUS OIL (UNII: 2R04ONI662) GLYCERIN (UNII: PDC6A3C0OX) CHAMOMILE (UNII: FGL3685T2X) ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1) ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H) MULLEIN LEAF (UNII: 9936O846LI) MUSA X PARADISIACA LEAF (UNII: 2UIJ27N6ED) RED CLOVER (UNII: L9153EKV2Y) URTICA DIOICA LEAF (UNII: X6M0DRN46Q) THYME (UNII: CW657OBU4N) HONEY (UNII: Y9H1V576FH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor CHERRY, BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43406-0664-4 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/07/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/07/2007 Labeler - Natural Creations, Inc. (018022074) Establishment Name Address ID/FEI Business Operations OHM Pharma, Inc. 030572478 manufacture(43406-0664)
