RUGBY COUGH GUAIFENESIN- guaifenesin liquid 
Unit Dose Services

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 Cough SYRUP Guaifenesin, 4 fl oz (118 mL)

Drug Facts

Active ingredient (in each 10 mL)

Guaifenesin, USP 200 mg

Purpose

Expectorant

Uses

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 last 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 at 1-800-222-1222.

Directions

do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided
keep dosing cup with product
mL=milliliter
this adult product is not intended for use in children under 12 years of age
agedose

adults and children 12 years and over

10 mL-20 mL every 4 hours

children under 12 years

do not use

Other information

each 10 mL contains:sodium 4 mg
store at 20-25°C (68-77°F).
alcohol-free

Inactive ingredients

citric acid, disodium edetate , FD&C red no. 40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions?

1-866-467-2748

Distributed by:
Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

www.rugbylaboratories.com

Re-order No.370448

Rev.10/15

R-107

HOW SUPPLIED

Product: 50436-1095

NDC: 50436-1095-1 1 mL in a CARTON / 118 in a BOTTLE

RUGBY COUGH SYRUP GUAIFENESIN (GUAIFENESIN) LIQUID

Label Image
RUGBY COUGH GUAIFENESIN 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50436-1095(NDC:0536-1095)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50436-1095-1118 in 1 BOTTLE01/08/2019
11 mL in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/20/2016
Labeler - Unit Dose Services (831995316)
Establishment
NameAddressID/FEIBusiness Operations
Unit Dose Services831995316REPACK(50436-1095) , RELABEL(50436-1095)

Revised: 1/2019
Document Id: fe47f81a-63a6-4c4d-91dc-88a0e32df57b
Set id: 7486c5ae-3e00-4c9f-bcb7-047a90af0f94
Version: 2
Effective Time: 20190108
 
Unit Dose Services