Cold Remedy Soothing
FDA Label NDC 51367-002

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 Soothing (NDC 51367-002). 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, uses, warnings, ask a doctor or pharmacist before use if you are, while taking this product, stop use and doctor if, directions, storage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Chlorphenamine Maleate 1.05 mg

Acetaminophen 105 mg

Uses

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

  • Fever
  • Itiching of the nose or throat
  • Minor aches and pains
  • Sneezing
  • Muscle aches
  • Headache
  • Runny nose
  • Itchy eyes

Warnings

Do Not Use:

  • Pain lasts more than 10 days
  • Fever lasts more than 3 days
  • If pregnant or breast-feeding, ask a health professional before using

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking other medications
  • Have glaucomea
  • A breathing problem such as emphysema or chronic bronchitis
  • Difficulty in urination due to enlargement of the prostate gland

While Taking This Product

Do not use this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product, may cause excitability, especially in children

May cause drowsiness. Alcohol, sedatives, and tranquilizers may increase the drowsiness effect.

Avoid alcoholic beverages

Use caution when driving a motor vehicle or operating machinery.

Stop Use And Doctor If

  • Condition worsens
  • Symptoms persit for more than 7 days
  • Symptoms clear up and occur again within a few days

Directions

Adults and children 12 years of age and older

  • Take 2 tablets every 4 hours, not to exceed more than 12 tablets in 24 hours

    • Children ages 6 to 12 years old

    • Take 1 tablet every 4 hours, not to exceed more than 6 tablets in 24 hours

      • Children under 6 years of age

      • Consult a doctor

Storage

Store at 15°C to 30°C (59°F to 86°F)

Keep away from heat

Store in a dry place

Inactive Ingredients

Lonicerae Flos, Weeping Forsythia Capsule, Fineleaf Schizonepeta Herb, Prepared Soybean, Lophatherum Herb, Great Burdock Achene, Reed Rhizome, Platycodon Root, Radix Glycyrrhizae, Vitamin C, Peppermint Oil.

Excipients:

Corn Starch, Stearic Acid, Microcrystalline Cellulose, Silicon Dioxide, Magnesium Stearate, Betadex, Lactose, Maltodextrin, FD&C Yellow No. 6, FD&C Green No. 3

Image

Image Of Packaging (Vit C)

Image Of Packaging (Vit C)

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