CHERACOL D COUGH FORMULA 4OZ- maximum strength cough relief syrup 
Lee Pharmaceuticals

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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Drug Facts

Active ingredients (5 mL teaspoonful)

Dextromethorphan HBr, 10mg

Guaifenesin, 100mg

Purpose

Cough suppressant

Expectorant

Uses

Warnings

Do not use

Ask a doctor before use if you have

  • a persistent chronic cough such as occurs with smoking, asthma or emphysema.
  • excessive phlegm (mucus).

Stop use and ask a doctor if

  • cough persists for more than one week
  • cough tends to recur or is accompanied by fever, rash or persistent headache.  A persistent cough may be a sign of a serious condition.

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

Keep out of reach of children.  In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

Other information

Store from 15° - 30°C (59° - 86°F)

Inactive ingredients

Alcohol 4.75%, benzoic acid, FD&C red #40, flavors, fructose, glycerin, propylene glycol, sodium chloride, sucrose, water.

Questions or Comments

label 4oz

carton 4oz

label 6oz

carton 6oz

CHERACOL D  COUGH FORMULA 4OZ
maximum strength cough relief syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23558-5504
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
FRUCTOSE (UNII: 6YSS42VSEV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SUCROSE (UNII: C151H8M554)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:23558-5504-01 in 1 CARTON
1NDC:23558-5504-1118 mL in 1 BOTTLE, PLASTIC
2NDC:23558-5504-21 in 1 CARTON
2NDC:23558-5504-3177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/01/2011
Labeler - Lee Pharmaceuticals (056425432)
Registrant - Lee Pharmaceuticals (056425432)
Establishment
NameAddressID/FEIBusiness Operations
Lee Pharmaceuticals056425432manufacture(23558-5504)

Revised: 12/2013
Document Id: b8f7b5eb-0477-4117-a170-cba92901808a
Set id: 6bbf5b3a-ecc2-46f7-84a9-db4d3fcf4100
Version: 3
Effective Time: 20131206
 
Lee Pharmaceuticals