FDA.reportPublic FDA data

Rapid Max Maximum Strength Cool and Clear - Cold, Severe Congestion and Cough

Manufacturer
KINGSTON PHARMA LLC
Effective date
2017-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:17

Label at a glance#

ProductRapid Max Maximum Strength Cool and Clear - Cold, Severe Congestion and Cough
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure12 sections

Storage and handling

Other information Store between 20-25 degree Celsius (68-77 degree Fahrenheit) Each tablespoon contains: Sodium 13mg

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

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 SECTION

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

Warnings:

OTC - DO NOT USE SECTION

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 SECTION

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

OTC - WHEN USING SECTION

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 SECTION

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 SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Other information

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

INACTIVE INGREDIENT SECTION

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 SECTION

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043543dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN1
1043543dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD1
1043543dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY1
1043543dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71027-020-062020-01-31C16284748780-19d75b9cf-d28c-f424-e053-dadaa90a57ceExcelMed Rapid Max Maximum Strength Cool & Clear- Cold, Severe Congestion & Cough

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71027-020-06Rapid Max Maximum Strength Cool and Clear - Cold, Severe Congestion and Cough1 in 1 CARTONLIQUID11
71027-020-06Rapid Max Maximum Strength Cool and Clear - Cold, Severe Congestion and Cough177 mL in 1 BOTTLELIQUID1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71027-020RAPID MAX MAXIMUM STRENGTH COOL AND CLEAR - COLD, SEVERE CONGESTION AND COUGH LIQUID [KINGSTON PHARMA LLC]1Legacy NDC, 2 package rows20170320_23c16cf9-b0c9-475c-8014-fca9a843ff56.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71027-02071027-020-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
METHYL SALICYLATELAV5U5022YIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM HYDROXIDE55X04QC32IIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
23c16cf9-b0c9-475c-8014-fca9a843ff5623c16cf9-b0c9-475c-8014-fca9a843ff562017-03-01WarningsExact identifier
spl id: 23c16cf9-b0c9-475c-8014-fca9a843ff56
spl set id: 23c16cf9-b0c9-475c-8014-fca9a843ff56

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.