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 
KINGSTON PHARMA LLC

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.

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

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

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

Uses

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 this product

Stop use and ask doctor if

These could be signs of a serious condition

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.

Directions:

Other information

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

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

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

Label
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)

Revised: 3/2017
Document Id: 23c16cf9-b0c9-475c-8014-fca9a843ff56
Set id: 23c16cf9-b0c9-475c-8014-fca9a843ff56
Version: 1
Effective Time: 20170301
 
KINGSTON PHARMA LLC