Label: CONGESTION HP- ammonium chloride, antimony potassium tartrate, arsenic trioxide, oyster shell calcium carbonate, crude, lobelia inflata, sodium sulfate, spongia officinalis skeleton, roasted, phosphorus liquid
- NDC Code(s): 43406-0626-1
- 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
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
-
WARNINGS
WARNINGS:
- Consult a physician for use in children under 12 years of age.
- IF PREGNANT OR BREAST-FEEDING, ask a health care 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.
- A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache consult a doctor.
- INACTIVE INGREDIENT
- QUESTIONS
- REFERENCES
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CONGESTION HP
ammonium chloride, antimony potassium tartrate, arsenic trioxide, oyster shell calcium carbonate, crude, lobelia inflata, sodium sulfate, spongia officinalis skeleton, roasted, phosphorus liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43406-0626 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMMONIUM CHLORIDE (UNII: 01Q9PC255D) (AMMONIUM CATION - UNII:54S68520I4) AMMONIUM CATION 30 [hp_X] in 1 mL ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY CATION (3+) 30 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC CATION (3+) 30 [hp_X] in 1 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_X] in 1 mL LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U) LOBELIA INFLATA 30 [hp_X] in 1 mL SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE 30 [hp_X] in 1 mL SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 30 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 30 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43406-0626-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 06/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/01/2016 Labeler - Natural Creations, Inc. (018022074) Establishment Name Address ID/FEI Business Operations OHM Pharma, Inc. 030572478 manufacture(43406-0626)
