GUAIFENESIN D- guaifenesin and pseudoephedrine hydrochloride tablet, extended release 
RUGBY LABORATORIES, INC.

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Guaifenesin D

Drug Facts

Active ingredients (in each extended-release tablet)Purposes

Guaifenesin 600 mg

Expectorant

Pseudoephedrine HCl 60 mg

Nasal Decongestant

Uses

•
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
•
temporarily relieves nasal congestion due to:
•
common cold
•
hay fever
•
upper respiratory allergies
•
temporarily restores freer breathing through the nose
•
promotes nasal and/or sinus drainage
•
temporarily relieves sinus congestion and pressure

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 MAOI 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

•
heart disease
•
high blood pressure
•
thyroid disease
•
diabetes
•
trouble urinating due to an enlarged prostate gland
•
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
•
cough accompanied by too much phlegm (mucus)

When using this product

•
do not use more than directed

Stop use and ask a doctor if

•
you get nervous, dizzy, or sleepless
•
symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

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 (1-800-222-1222).

Directions

•
do not crush, chew, or break extended-release tablet
•
take with a full glass of water
•
this product can be administered without regard for timing of meals
•
adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
•
children under 12 years of age: do not use

Other information

•
Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
•
store between 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer, NF; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF

Questions?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-645-2158. You may also report side effects to this phone number.

Distributed by:
RUGBY® LABORATORIES
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 36 Tablet Blister Pack Carton

Rugby®

NDC 0536-1333-36

Compare to the active
ingredients in Mucinex® D†

Guaifenesin and
Pseudoephedrine HCl
Extended-Release Tablets
Guaifenesin 600 mg
Pseudoephedrine HCl 60 mg

600 mg/60 mg

Expectorant and Nasal Decongestant

12 Hour

•
Clears Nasal/Sinus Congestion
•
Thins and Loosens Mucus
•
Immediate and Extended Release

Actual Size

36 Extended-Release Tablets

PRINCIPAL DISPLAY PANEL - 36 Tablet Blister Pack Carton
GUAIFENESIN D 
guaifenesin and pseudoephedrine hydrochloride tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1333
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin600 mg
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride60 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize16mm
FlavorImprint Code 058
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1333-362 in 1 CARTON04/04/2022
118 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0536-1333-211 in 1 CARTON04/04/2022
218 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21254204/04/2022
Labeler - RUGBY LABORATORIES, INC. (079246066)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(0536-1333)

Revised: 5/2022
Document Id: 4f4c9058-ec1c-48d5-81df-56188b7ae803
Set id: 997946e6-eff0-4c15-8694-020a19c2d336
Version: 4
Effective Time: 20220516
 
RUGBY LABORATORIES, INC.