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  5. Label Information: Rapid Max Maximum Strength Cool And Clear - Cold, Flu And Sore Throat

FDA Label for Rapid Max Maximum Strength Cool And Clear - Cold, Flu And Sore Throat

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - WHEN USING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. DOSAGE & ADMINISTRATION
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT
    13. HOW SUPPLIED

Rapid Max Maximum Strength Cool And Clear - Cold, Flu And Sore Throat Product Label

The following document was submitted to the FDA by the labeler of this product Kingston Pharma Llc. 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.

Otc - Active Ingredient



Active Ingredient: Each 20ml contains:
Acetaminophen 650 mg
Dextromethorphan 20 mg
Guaifenesin 400 mg
Phenylephrine 10 mg


Otc - Purpose



Purpose:
Pain reliever, Fever Reducer
Cough Suppressant
Expectorant
Nasal Decongestant


Indications & Usage



Uses

  • Temporarily relieves these common cold/flu symptoms
    • Minor aches and pains
    • Headache
    • Sore throat
    • Nasal congestion
    • Fever
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings



DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.

Warnings:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes

  • More than 4 doses in 24 hours, which is the maximum daily amount for this product.
  • With other drugs containing acetaminophen.
  • Adult has 3 or more alcoholic drinks every day while using this product.

    • Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.


Otc - Do Not Use



Do not use

  • for children under 12 years of age
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Otc - Ask Doctor



Ask a doctor before use if you have

  • diabetes
  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland

    • Ask a doctor or pharmacist before use if you are

    • Taking the blood thinning drug warfarin

Otc - When Using



When using this product

  • Do not exceed recommended dosage (see overdose warning)

    • Stop use and ask doctor if

    • Nervousness, dizziness or sleeplessness occur
    • Symptoms get worse or last more than 5 days (children) or 7 days (adults)
    • Fever gets worse or lasts more than 3 days
    • Redness or swelling is present
    • New symptoms occur
    • Cough comes back or occurs with rash or headache that lasts

      • These could be signs of a serious condition


Otc - Keep Out Of Reach Of Children



Keep this and all drugs out of the reach of children.

Overdose Warning: In case of accidental overdose, seek professional assistance or contact a Poison control center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

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


Otc - Pregnancy Or Breast Feeding



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


Dosage & Administration



Directions:

  • Do not take more than directed. (see overdose warning)
  • Use enclosed dosing cup.
  • Do not take more than 4 doses in 24-hours.
  • Adults and children 12 years and over: take 2 tablespoons (TBSP) or 30 mL every 4 hours.
  • Children 6 to under 12 years: take 1 tablespoon (TBSP) or 15 mL every 4 hours.
  • Children 4 to under 6 years: ask a doctor
  • Children under 4 years: do not use
  • When using other Daytime or Nite time products, carefully read each label to insure correct dosing

Storage And Handling



Other information

  • Store between 20-25 degree Celsius (68-77 degree Fahrenheit)
  • Each tablespoon contains: Sodium 50mg

Inactive Ingredient



Inactive ingredients Anhydrous Citric Acid, Disodium EDTA-Copper, Sodium Benzoate, Sucralose, Sodium Citrate, Propyl Gallate, Xanthan gum, Glycerin, Propylene glycol, Sorbitol, FD&C Blue#1, FD&C Red# 40 and Purified Water.


How Supplied



(packs: 6oz) Kingston NDC# 71027-019-06

Manufactured by: Kingston Pharma LLC
5 County Route 42
Massena, NY 13662


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