Label: COUGHEX SPRINKLES- aconitum nap, hepar sulph calc, kali mur, mag phos, rumex crisp granule
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Contains inactivated NDC Code(s)
NDC Code(s): 68703-040-20 - Packager: Native Remedies, LLC
- 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 November 27, 2012
If you are a consumer or patient please visit this version.
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- PURPOSE
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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INFORMATION FOR PATIENTS
The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
All Native Remedies health products are especially formulated by experts in the field of natural health, and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com
Distributed by
Native Remedies, LLC
6531 Park of Commerce Blvd
Suite 160
Boca Raton, FL 33487
Phone: 1.877.289.1235
International: +1.561.999.8857Contain no artificial flavors or artificial colors. No gluten added.
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COUGHEX SPRINKLES
aconitum nap, hepar sulph calc, kali mur, mag phos, rumex crisp granuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68703-040 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 30 [hp_C] in 16 mg CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 6 [hp_C] in 16 mg POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 6 [hp_X] in 16 mg MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 8 [hp_X] in 16 mg RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT 6 [hp_C] in 16 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) STARCH, CORN (UNII: O8232NY3SJ) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SUCROSE (UNII: C151H8M554) Product Characteristics Color white (White lactose granules) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68703-040-20 20000 mg in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/27/2012 Labeler - Native Remedies, LLC (192014186) Establishment Name Address ID/FEI Business Operations King Bio 617901350 manufacture(68703-040) , api manufacture(68703-040)