RITUSSIN DM- dextromethorphan hydrobromide and guaifenesin liquid

Ritussin DM by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients (in each 5 mL)(one teaspoonful)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Purpose

Cough suppressant

Expectorant

Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with cold

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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

• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough 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 of age and over	2 teaspoonfuls every 4 hours
children 6 years to under 12 years of age	1 teaspoonful every 4 hours
children 2 years to under 6 years of age	1/2 teaspoonful every 4 hours
under 2 years of age	ask a doctor

Other information

• store at room temperature 15º - 30ºC (59º - 86ºF)
• protect from freezing.
• protect from light.
• Each teaspoon (5 mL) contains: sodium 2 mg.
• TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING

Inactive ingredients

citric acid, FD&C Red #40, flavors, glucose, glycerin, high fructose corn syrup, menthol, saccharin sodium, sodium benzoate, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RITUSSIN DM 
dextromethorphan hydrobromide and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53807-409
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
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: 53807-409-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/1999
2	NDC: 53807-409-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/1999
3	NDC: 53807-409-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/1999
4	NDC: 53807-409-28	3785 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(53807-409)