1. Home
  2. Labeler Index
  3. International Nature Nutraceuticals
  4. 51367-002
  5. Label Information: Cold Remedy Soothing

FDA Label for Cold Remedy Soothing

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. USES
    3. WARNINGS
    4. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    5. WHILE TAKING THIS PRODUCT
    6. STOP USE AND DOCTOR IF
    7. DIRECTIONS
    8. STORAGE
    9. INACTIVE INGREDIENTS
    10. IMAGE

Cold Remedy Soothing Product Label

The following document was submitted to the FDA by the labeler of this product International Nature Nutraceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.