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Extra action Cough

Dosage form: liquid
Ingredients: Guaifenesin 100mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL
Labeler: Rugby Laboratories Inc.
NDC Code: 0536-0970

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.

Rugby ®
EXTRA
ACTION
Cough
SYRUP

Drug Facts

Active ingredients (in each teaspoonful [TSP]) Purposes
Dextromethorphan HBr USP 10 mgAntitussive
Guaifenesin USP 100 mgExpectorant

Uses
  • temporarily quiets cough caused by the common cold or inhaled irritants
  • helps loosen phlegm 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before use.

Ask a doctor before use if you have
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough 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 occurs with 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
  • take every 4 hours
  • do not take more than 6 doses in 24 hours
  • use only with enclosed dose cup. Do not use with any other device.
adults and children 12 years and over2 TSP
children 6 to under 12 years1 TSP
children under 6 yearsdo not use

Other information
  • each TSP contains: sodium 3 mg
  • store at room temperature 15°-30° C (59°-86°F)

Inactive ingredients

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

Questions or comments?

call 1-800-645-2158, 9 am - 5 pm ET, Monday - Friday

Extra Action Cough Syrup is distributed by Rugby Laboratories, Inc.
Duluth, Georgia 30097

PRINCIPAL DISPLAY PANEL - 118 mL Carton

COMPARE TO
ACTIVE INGREDIENTS IN
ROBITUSSIN® DM*

NDC 0536-0970-97

Rugby ®

  • COUGH
    SUPPRESSANT
  • NON-NARCOTIC
    EXPECTORANT

EXTRA
ACTION
Cough
SYRUP

Guaifenesin with
Dextromethorphan

4 fl oz
(118 mL)

SATISFACTION GUARANTEED
Rugby
OR YOUR MONEY BACK

EXTRA ACTION COUGH 
guaifenesin and dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-0970
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate 
Corn Syrup 
FD&C Red no. 40 
Glycerin 
Menthol 
Cherry 
Water 
Sodium Benzoate 
Saccharin Sodium 
Product Characteristics
ColorPINK (Reddish-Pink) Score    
ShapeSize
FlavorMENTHOL, CHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-0970-97118 mL in 1 BOTTLE
2NDC:0536-0970-85473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/03/2011
Labeler - Rugby Laboratories Inc. (109178264)

Revised: 07/2011
 
Rugby Laboratories Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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