EXTRA ACTION COUGH- guaifenesin and dextromethorphan hydrobromide liquid 
Rugby Laboratories Inc.

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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Rugby ®



EXTRA



ACTION



Cough



SYRUP

Drug Facts

Active ingredients (in each 2 teaspoonfuls (10 mL)) Purposes
Dextromethorphan HBr USP 20 mgCough Suppressant
Guaifenesin USP 200 mgExpectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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 MAOl 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 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 headache that lasts. 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
  • this product is not intended for use in children under 12 years of age
adults and children 12 years and over2 teaspoonfuls every 4 hours
children under 12 yearsdo not use

Other information

  • each teaspoonful (5mL) contains: sodium 3 mg
  • store at 20°- 25°C (68°- 77°F) . Do not refrigerate.

Inactive Ingredients

Artificial cherry flavor, citric acid, corn syrup, FD&C Red #40, glycerin, menthol, purified water, saccharin sodium, sodium benzoate.

Questions or comments?

1-800-645-2158

Distributed by:
Rugby Laboratories
17177 N Laurel Park Drive,
Suite 233
Livonia, MI 48152 USA

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

COMPARE TO
ACTIVE INGREDIENTS IN
ROBITUSSIN ® COLD COUGH+CHEST
CONGESTION DM*

Rugby ®

NDC 0536-0970-85

Non-narcotic Cough Suppressant
and Expectorant

EXTRA ACTION

Cough Syrup

(Guaifenesin with
Dextromethorphan HBr Syrup)

TAMPER EVIDENT: DO NOT USE IF
INNER FOIL SEAL OVER MOUTH OF
BOTTLE IS BROKEN OR MISSING

This is a bulk package, not intended for households
with young children. Dispense contents with a child-
resistant closure in a tight, light-resistant container
as defined in the USP.

*Rugby Laboratories is not affiliated with the owner
ROBITUSSIN ® COLD COUGH+CHEST CONGESTION DM

Distributed by:
Rugby Laboratories
17177 N Laurel Park Drive,
Suite 233
Livonia, MI 48152 USA
www.rugbylaboratories.com

One Pint (473 mL)

Re-order No. 370054
Rev. 03/17
R-64

Principal Display Panel - 473 mL Bottle Label
EXTRA ACTION COUGH 
guaifenesin and dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-0970
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CORN SYRUP (UNII: 9G5L16BK6N)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
CHERRY (UNII: BUC5I9595W)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Colorpink (Reddish-Pink) Score    
ShapeSize
FlavorMENTHOL, CHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-0970-97118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/03/201103/30/2020
2NDC:0536-0970-85473 mL in 1 BOTTLE; Type 0: Not a Combination Product02/03/201105/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/03/201105/31/2020
Labeler - Rugby Laboratories Inc. (079246066)

Revised: 9/2019
Document Id: 93644445-2b0d-0607-e053-2995a90ab227
Set id: 57532015-f4ed-4c5b-b805-57cf8202ed25
Version: 4
Effective Time: 20190925
 
Rugby Laboratories Inc.