Otc - Active Ingredient
Active Ingredient: Each 20ml contains:
Dextromethorphan 20 mg
Guaifenesin 400 mg
Phenylephrine 10 mg
Rapid Max Maximum Strength Cool And Clear - Cold, Severe Congestion And Cough
FDA Label NDC 71027-020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kingston Pharma Llc for the product Rapid Max Maximum Strength Cool And Clear - Cold, Severe Congestion And Cough (NDC 71027-020). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- Cough due to minor throat and bronchial irritation
Warnings
DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.
Warnings:
Otc - Do Not Use
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.
Otc - Ask Doctor
- 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
- Taking the blood thinning drug warfarin
Ask a doctor or pharmacist before use if you are
Otc - When Using
When using this product
- Do not exceed recommended dosage (see overdose warning)
- 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
Stop use and ask doctor if
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.
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 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
* Please review the disclaimer below.
