Label: AJOLOTIUS- syrup plant mix syrup

  • NDC Code(s): 84370-102-01
  • Packager: Camacho Navarrete, Jose Luis
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 6, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • WARNINGS

    Do not give this product for persistent or chronic cough such as occurs with asthma or if cough is accompanied by excesive phlegm (mucus) unles directed by a doctor.
    Stop use and ask a doctor if cough persist for more than 1 week, tends to recur or is accompanied by fever, rash or persistent headache, as a persistent cough may be a sing of a serious condition.
    If pregnant or breast feeding, ask a health professional before use.

  • INDICATIONS & USAGE

    For the relief of the symptoms of the common cold and cough.

  • DOSAGE & ADMINISTRATION

    Children over 2 years take one teaspoon (2.5 mL) every 6 hours during the day.
    Adults: Take one jtablespoon (5 mL) every 6 hours during the day.

  • DOSAGE FORMS & STRENGTHS

    Oral administration.

  • CONTRAINDICATIONS

    Hypersensitivity to the components of the formula.
    Do not administer to children under 2 years of age, or to diabetic patients without medical supervision.

    Do not use during pregnancy and breastfeeding without medical supervision.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medial help or contact a Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.

  • ACTIVE INGREDIENT

    EUCALYPTUS GLOBULUS LEAF

  • INACTIVE INGREDIENT

    VERBASCUM THAPSUS
    INVERT SUGAR
    MENTHA PIPERITA
    WATER
    BOUGAINVILLEA GLABRA FLOWER

  • PURPOSE

    For the relief of the symptoms of the common cold and cough.

  • PRINCIPAL DISPLAY PANEL

    84370-102-01 250 mL Label

  • INGREDIENTS AND APPEARANCE
    AJOLOTIUS 
    syrup plant mix syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84370-102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF0.0002 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    VERBASCUM THAPSUS (UNII: C9TD27U172) 0.0002 g  in 100 g
    INVERT SUGAR (UNII: ED959S6ACY) 80 g  in 100 g
    MENTHA PIPERITA (UNII: 79M2M2UDA9) 0.0002 g  in 100 g
    WATER (UNII: 059QF0KO0R)  
    BOUGAINVILLEA GLABRA FLOWER (UNII: V5FW05GP6R) 0.0002 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84370-102-01250 g in 1 BOTTLE; Type 0: Not a Combination Product01/06/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/06/2024
    Labeler - Camacho Navarrete, Jose Luis (951750834)
    Registrant - Camacho Navarrete, Jose Luis (951750834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Camacho Navarrete, Jose Luis951750834manufacture(84370-102)