COUGH FORMULA COUGH AND COLD- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Cough Formula Cough and Cold by

Drug Labeling and Warnings

Cough Formula Cough and Cold by is a Otc medication manufactured, distributed, or labeled by Rij Pharmaceutical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mLtsp)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Phenylephrine HCl, USP 5 mg

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to to drain bronchial tubes

temporarily relieves these symptoms occuring with a cold

nasal congestion

cough due to minor throat and bronchial irritation

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.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product do not use more than directed.

Stop use and ask a doctor if

• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• cough that lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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

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

Directions

• do not take more than 6 doses in any 24-hour period

age	dose
adults and children 12 years and over	2 teaspoonfuls every 4 hours
children 6 years to under 12 years	1 teaspoonful every 4 hours
children 2 years to under 6 years	1/2 teaspoonful every 4 hours
children under 2 years	ask a doctor

Other information

• TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING
• store at room temperature 15º - 30ºC (59º - 86ºF)
• alocohol free
• not a USP elixir
• each teaspoon (5 mL) contains: sodium 2 mg.

Inactive ingredients

citric acid, FD&C red no. 40, , flavors, glycerin, menthol, propylene glycol, sodium benzoate, sodium saccharin, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COUGH FORMULA COUGH AND COLD 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53807-531
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MENTHOL (UNII: L7T10EIP3A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53807-531-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/1999
2	NDC: 53807-531-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/1999

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/16/1999

Labeler - Rij Pharmaceutical Corporation (144679156)

Establishment
Name	Address	ID/FEI	Business Operations
Rij Pharmaceutical Corporation		144679156	manufacture(53807-531)