Label: RAPID MAX MAXIMUM STRENGTH COOL AND CLEAR - COLD, SEVERE CONGESTION AND COUGH liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 1, 2017

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  • ACTIVE INGREDIENT

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

  • PURPOSE

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

  • INDICATIONS & USAGE

    Uses

    • Temporarily relieves these common cold/flu symptoms
      1. Minor aches and pains
      2. Headache
      3. Sore throat
      4. Nasal congestion
      5. Fever
      6. Cough due to minor throat and bronchial irritation
  • WARNINGS

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

    Warnings:

    Do not use

    • 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.
    • If you have ever had an allergic reaction to this product or any of its ingredients.

    Ask a doctor before use if you have

    • Liver disease
    • Heart disease
    • High blood pressure
    • Thyroid disease
    • Diabetes
    • Trouble urinating due to an enlarged prostate gland
    • Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • Cough that occurs with too much phlegm (mucus)
    • A Sodium restricted diet

    Ask a doctor or pharmacist before use if you are

    • Taking the blood thinning drug warfarin
  • 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

  • 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.

  • 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 20 mL every 4 hours.
    • Children under 12 years: do not use
  • STORAGE AND HANDLING

    Other information

    • Store between 20-25 degree Celsius (68-77 degree Fahrenheit)
    • Each tablespoon contains: Sodium 13mg
  • INACTIVE INGREDIENT

    Inactive ingredients citric acid, dextrose, flavors, glycerin, methyl paraben, potassium sorbate, propylene glycol, propyl paraben, purified water, red 33, red 40, saccharin sodium, sodium hydroxide, sucralose, xanthan gum

  • HOW SUPPLIED

    (packs: 6oz) Kingston NDC# 71027-020-06

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

  • PRINCIPAL DISPLAY PANEL

    Label
  • INGREDIENTS AND APPEARANCE
    RAPID MAX MAXIMUM STRENGTH COOL AND CLEAR - COLD, SEVERE CONGESTION AND COUGH 
    rapid max maximum strength cool and clear - cold, severe congestion and cough liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71027-020
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71027-020-061 in 1 CARTON03/01/2017
    1177 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2017
    Labeler - KINGSTON PHARMA LLC (080386521)
    Registrant - KINGSTON PHARMA LLC (080386521)
    Establishment
    NameAddressID/FEIBusiness Operations
    KINGSTON PHARMA LLC080386521manufacture(71027-020)
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