Cold Remedy Gan Mao Ling
FDA Label NDC 51367-005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by International Nature Nutraceuticals for the product Cold Remedy Gan Mao Ling (NDC 51367-005). 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 active ingredients, when using this product, uses, warnings, ask a doctor/pharmacist before use, directions:, inactive ingredients, storage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Caffeine- 1mg

Chlorpheniramine Maleate- 1mg

Acetaminophen- 50mg

When Using This Product

May occur drowsiness

avoid alcoholic drinks

use caution when you driving a motor vehicle or operating machinery

may occur excitability especially in children

 

Uses

Temporarily relieves the following symptoms associated with the common cold, hay fever, or other upper respiratory allergies

  • fever
  • headache
  • runny nose
  • itching of the nose or throat
  • minor aches and pains
  • sore throat

Warnings

Do not use if:

  • Condition worsens
  • pain lasts more than 7 days
  • fever lasts more than 3 days
  • if pregnant or breast-feeding, consult a doctor before using

Ask A Doctor/Pharmacist Before Use

Ask before use if you have:

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • taking sedatives or tranquilizers

Directions:

Adults and children 12 years of age and older:

  • take 4 tablets every 4 hours, not more than 12 tablets in 24 hours

    • Children 6 to 12 years old

    • take 2 tablets every 4 hours, not more than 6 tablets in 24 hours

      • Children under 6 years:

      • consult a doctor

Inactive Ingredients

金盏银盘 Bidens Pilosa Whole 野菊花。  Dendranthema indicum flower. 薄荷油.  Mentha arvensis flower oil. 岗梅 ilex Pedunculosa whole

Storage

Store at 15°C to 30°C  (59°F to 86°F)

keep away from heat

keep in dry place

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