PSEUDO EPHED PLUS- pseudoephedrine hydrochloride, guaifenesin tablet 
Dickey Consumer Products DBA DMD

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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DRUG FACTS

Active Ingredient(In Each Tablet): Pseudoephedrine HCl 30 mg, Guaifenesin 200 mg

Purposes - Nassal Decongestant, Expectorant

• temporarily relieves nasal congestion due to the common cold • promotes nasal and/or sinus drainage • temporarily relieves sinus congestion and pressure • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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 • a cough accompanied by excessive phlegm (mucus)

When using this product • do not use more than directed • intentional abuse of this product can be harmful or fatal

Stop use and ask a doctor if: • you get nervous dizzy or sleepless • 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. • symptoms do not get better within 7 days or occur with a fever

If pregnant or breast feeding, ask a health proffessional before use.

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

• adults and children 12 years of age and over: take 2 tablets every 4 to 6 hours; do not exceed 8 tablets in 24 hours • children under 12 years of age: ask a doctor

Inactive Ingredients: Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Stearic Acid

Pseudo Ephed Plus 24ct

PSEUDO EPHED PLUS 
pseudoephedrine hydrochloride, guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65193-325
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 (UNII: U725QWY32X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Product Characteristics
Colorwhite (snow white) Scoreno score
ShapeROUND (EP230) Size9mm
FlavorImprint Code EP230
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65193-325-2424 in 1 BLISTER PACK; Type 0: Not a Combination Product03/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/15/2019
Labeler - Dickey Consumer Products DBA DMD (835974056)
Registrant - Dickey Consumer Products DBA DMD (835974056)
Establishment
NameAddressID/FEIBusiness Operations
Ultratab Laboratories, Inc.151051757manufacture(65193-325)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corp.085752004pack(65193-325)

Revised: 3/2019
Document Id: 865da4b2-08e5-4d75-b672-dc1ee6a464bd
Set id: 848c680c-22c4-4b43-bc3a-21ff72e88888
Version: 1
Effective Time: 20190320
 
Dickey Consumer Products DBA DMD