Label: REGULAR REMEDIES NO. 16- alumina, bellis perennis, causticum, collinsonia canadensis, hydrastis canadensis, lac defloratum, natrum muriaticum, nux vomica, plumbum metallicum, sepia liquid

  • 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 July 30, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient HPUS: Alumina, Bellis perennis, Causticum, Collinsonia canadensis, Hydrastis canadensis, Lac defloratum, Natrum muriaticum, Nux vomica, Plumbum metallicum, Sepia. Equal volumes of each ingredient in: 10X, 30X, LM1 potencies

    HPUS indicates that this ingredient is officially part of the Homeopathic Pharmacopia of the United States.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Citric acid, Potassium sorbate, Purified water.

  • INDICATIONS & USAGE

    Uses: Temporarily relieves symptoms of:

    • Occasional constipation and irregularity
    • Infrequent urges and peristaltic action
  • DOSAGE & ADMINISTRATION

    Directions: Hold close to mouth and spray directly into mouth. Use 3 times daily. Use additionally as needed. Adult Dose: 3 pump sprays. Children 2-12 years: 2 pump sprays.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • WARNINGS

    Warnings:

    Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur. If pregnant or breastfeeding, consult a doctor before use.

  • OTHER SAFETY INFORMATION

    Other Information: Tamper resistant for your protection. Use only if safety seal is still intact.

  • PURPOSE

    Uses: Temporarily relieves symptoms of: occasional constipation and irregularity, infrequent urges and peristaltic action

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    REGULAR REMEDIES NO. 16 
    alumina, bellis perennis, causticum, collinsonia canadensis, hydrastis canadensis, lac defloratum, natrum muriaticum, nux vomica, plumbum metallicum, sepia liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55926-0016
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933) ALUMINUM OXIDE10 [hp_X]  in 59 mL
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS10 [hp_X]  in 59 mL
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM10 [hp_X]  in 59 mL
    COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR) COLLINSONIA CANADENSIS ROOT10 [hp_X]  in 59 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL10 [hp_X]  in 59 mL
    SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A) SKIM MILK10 [hp_X]  in 59 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE10 [hp_X]  in 59 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED10 [hp_X]  in 59 mL
    LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P) LEAD10 [hp_X]  in 59 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55926-0016-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/17/2013
    Labeler - Speer Laboratories, LLC (064900125)
    Registrant - Speer Laboratories, LLC (064900125)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350api manufacture(55926-0016)
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