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Cough by Rugby Laboratories Inc.

Medically reviewed on August 31, 2017

Dosage form: liquid
Ingredients: Guaifenesin 100mg in 5mL
Labeler: Rugby Laboratories Inc.
NDC Code: 0536-0825

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.

Cough Syrup

Drug Facts

Active ingredient (in each 2 TSP (10mL))

Guaifenesin USP 200 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 persistant 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
  • this product is not intended for use in children under 12 years of age
  • TSP=teaspoonful
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over2–4 TSP every 4 hours
children under 12 yearsdo not use

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

Inactive ingredients

caramel powder, citric acid, corn syrup FD&C red #40, glycerin, menthol, propylene glycol, 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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Rugby®
NDC 0536-0825-85

Compare to
Active Ingredient in
Robitussin® Mucus Plus
Chest Congestion*

Alcohol-Free Non-Narcotic
Expectorant

Cough
Syrup

(Guaifenesin Syrup, USP)

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.

One Pint (473 mL)

COUGH 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-0825
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Caramel 
Anhydrous Citric Acid 
Corn Syrup 
FD&C Red No. 40 
Glycerin 
Menthol, Unspecified Form 
Propylene Glycol 
Water 
Sodium Benzoate 
Saccharin Sodium 
Product Characteristics
ColorBROWN (Reddish-Brown) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-0825-97118 mL in 1 BOTTLE
2NDC:0536-0825-85473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/04/2009
Labeler - Rugby Laboratories Inc. (079246066)

 
Rugby Laboratories Inc.

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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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