Han Honey Loquat Syrup
FDA Label NDC 62003-888

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prince Of Peace Enterprises Inc. for the product Han Honey Loquat Syrup (NDC 62003-888). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, uses for the temporary relief of pain, warnings, otc - when using, stop use and ask a doctor if, otc - do not use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

  • Menthol 0.1%......................................Oral Pain Reliever

Indications & Usage

Uses For The Temporary Relief Of Pain

  • due to minor irritation of the mouth and gumsdue to minor irritation of the mouth and gums
    • due to sore mouth
      • due to sore throat

Warnings

Otc - When Using

  • Do not exceed recommended dosage

Stop Use And Ask A Doctor If

  • sore throat is severe or persists for more than 2 days, or is accompanied by high fever, headache, rash, swelling, nausea, or vomiting
    • sore mouth symptoms do not improve in 7 days
      • irritation, pain, or redness persists or worsens
        • Children under 3 years of age

Otc - Do Not Use

  • Do not use otherwise than as directed

Otc - Keep Out Of Reach Of Children

  • Keep this and all drugs out of reach of children.
    • In the case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Otc - Pregnancy Or Breast Feeding

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

Directions

 Adults and children 12 years of age and older Take 2 teaspoonful every 4 to 6 hours or as directed by a doctor.
 Children over 3 years of age Take 1 teaspoonful every 4 to 6 hours or as directed by a doctor.
 Children under 3 years of age Not recommended

Other Safety Information

  • store at cool room temperature, less than 20°C (less than 68°F)

Otc - Questions

  • -510-887-1899 Monday to Friday, 8am - 5pm Pacific Standard Time
  • www.popus.com

Inactive Ingredient

  • Maltose, Honey, Loquat leaf, Grosvenor Momordica fruit, Fritillary bulb, Stemona root, Bitter Apricot seed, Hogfennel root, Licorice root

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