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

Cheracol D by

Drug Labeling and Warnings

Cheracol D by is a Otc medication manufactured, distributed, or labeled by Lee Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (5 mL teaspoonful)

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

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INGREDIENTS AND APPEARANCE

CHERACOL D  COUGH FORMULA 4OZ
maximum strength cough relief syrup

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23558-5504-0	1 in 1 CARTON
1	NDC: 23558-5504-1	118 mL in 1 BOTTLE, PLASTIC
2	NDC: 23558-5504-2	1 in 1 CARTON
2	NDC: 23558-5504-3	177 mL in 1 BOTTLE, PLASTIC

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

Labeler - Lee Pharmaceuticals (056425432)

Registrant - Lee Pharmaceuticals (056425432)

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