CHERACOL D COUGH FORMULA 4OZ- dextromethorphan hydrobromide and guaifenesin 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

Dextromethorphan HBr, 10mg

Guaifenesin, 100mg

Purpose

Cough suppressant

Expectorant

Uses

Temporarily quiets coughs due to minor throat and bronchial irritation associated with the common cold.
Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

Warnings

Do not use

if you are now taking a perscription 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're uncertain whether your prescription drug contains MAOI, ask a doctor or pharmacist before taking this product.

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

Follow dosage below or use as directed by a doctor
Do not exceed 6 dosages in 24 hours
Adults and children 12 years or age and over, 2 teaspoonfuls every 4 hours
Children 6 to under 12 years of age, 1 teaspoonful every 4 hours
Children under 6 years of age, consult a doctor

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

1-800-950-5337, M-F, 9am-4pm, PST
Visit our website at: www.leepharmaceuticals.com

label

carton

CHERACOL D COUGH FORMULA 4OZ
maximum strength cough relief syrup

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:23558-5504
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg in 5 mL
GUAIFENESIN (GUAIFENESIN)	GUAIFENESIN	100 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40
GLYCERIN
PROPYLENE GLYCOL
WATER
FRUCTOSE
SODIUM CHLORIDE
SUCROSE
BENZOIC ACID
ALCOHOL

#	Item Code	Package Description
Packaging
1	NDC:23558-5504-0	1 in 1 CARTON
1	NDC:23558-5504-1	118 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	12/01/2011

Labeler - Lee Pharmaceuticals (056425432)

Registrant - Lee Pharmaceuticals (056425432)

Name	Address	ID/FEI	Business Operations
Establishment
Lee Pharmaceuticals		056425432	manufacture(23558-5504)

Revised: 11/2013

Document Id: ee9bfee6-09c4-41b4-b11e-4fe5311f0b9a

Set id: 6bbf5b3a-ecc2-46f7-84a9-db4d3fcf4100

Version: 1

Effective Time: 20131122

Lee Pharmaceuticals

﻿Drug Facts

Active ingredients

﻿Purpose

﻿Uses

﻿Warnings