RITUSSIN EXPECTORANT- guaifenesin liquid 
Rij Pharmaceutical Corporation

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 ingredient (in each 5 mL)(one teaspoonful)

Guaifenesin, USP 100 mg

Purpose

Expectorant

Use

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

Warnings

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

agedose
adults and children 12 years of age and over2-4 teaspoons every 4 hours
children 6 years to under 12 years of age1-2 teaspoonful every 4 hours
children 2 years to under 6 years of age1/2-1 teaspoonful every 4 hours
children under 2 years of ageask 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

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

PRINCIPAL DISPLAY PANEL

Principal Display Panel

RITUSSIN EXPECTORANT 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-408
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARAMEL (UNII: T9D99G2B1R)  
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
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53807-408-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
2NDC:53807-408-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
3NDC:53807-408-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
4NDC:53807-408-283785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/16/1999
Labeler - Rij Pharmaceutical Corporation (144679156)
Establishment
NameAddressID/FEIBusiness Operations
Rij Pharmaceutical Corporation144679156manufacture(53807-408)

Revised: 4/2018
Document Id: fc28d7de-7f4e-4327-9101-d33680f8d5c8
Set id: e89aed0d-fff1-4781-bdd9-ac614457c1f6
Version: 2
Effective Time: 20180430
 
Rij Pharmaceutical Corporation