RAPID MAX MAXIMUM STRENGTH COOL AND CLEAR - COLD, FLU AND SORE THROAT- rapid max maximum strength cool and clear - cold, flu and sore throat 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, Flu & Sore throat

Active Ingredient: Each 20ml contains:
Acetaminophen 650 mg
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:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes

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.

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.

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

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.

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

Directions:

Other information

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.

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

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

Label
RAPID MAX MAXIMUM STRENGTH COOL AND CLEAR - COLD, FLU AND SORE THROAT 
rapid max maximum strength cool and clear - cold, flu and sore throat liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71027-019
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71027-019-061 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(71027-019)

Revised: 3/2017
Document Id: 097e4c7b-b447-4728-b012-49d6562f3373
Set id: 097e4c7b-b447-4728-b012-49d6562f3373
Version: 1
Effective Time: 20170301
 
KINGSTON PHARMA LLC