EPHED PLUS SINUS - acetaminophen, pseudoephedrine hcl 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 Ingredients/tablet: Acetaminophen 325 mg

                                     Pseudoephedrine HCl 30 mg

Purpose: Pain Reliever, Nasal Decongestant

Indications: temporarily:

•    relieves nasal congestion associated with sinusitis 

•    relieves nasal congestion due to the common cold, hay fever or other 

upper respiratory allergies 

•    relieves sinus congestion and pressure ,helps decongest sinus openings and passages 

•    restores free breathing

temporarily relieves minor aches, pains, and fever associated with:

•    headache 

•    common cold

•    toothache

•    backache

•    muscular aches

•    menstrual cramps

Warnings:

Liver Warning: This product contains acetaminophen. Severe liver damage

     may occur if you take:

•    more than 8 tablets in 24 hours

•    with other drugs containing acetaminophen (prescription or nonprescription).  Ask a doctor or pharmacist before using with other drugs if you are not sure.  

•    3 or more alcoholic drinks every day while using this product

•    

Do not use:

•    with any other product containing acetaminophen this will provide more  

than the recommended dose (overdose) of acetaminophen and could  

cause serious health concerns.  

•    for more than 10 days for pain unless directed by a doctor

•    for more than 3 days for fever unless directed by a doctor

•    when using this product do not exceed recommended dose.

•    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 MAOI drug. If you do not know if your prescription  

drug contains an MAOI, consult a doctor or pharmacist before  

taking this product

Stop use and ask a doctor if:

•    symptoms do not improve

•    pain or fever persists or gets worse

•    new symptoms occur

•    redness or swelling is present

•    nervousness, dizziness or sleeplessness occur

•    symptoms do not improve within 7 days or are accompanied by  

fever

Ask a doctor before use if you have:

•    heart disease

•    high blood pressure

•    thyroid disease

•    diabetes

•    difficulty in urination due to enlargement of the prostate gland


Keep out of reach of children

Directions:

Adults and children 12 years of age and older

•    Take 2 tablets every 4 to 6 hours as needed, do not exceed 8 

tablets in 24 hours, or as directed by a doctor.

•    Children under 12 years, consult a doctor


Inactive Ingredients: Corn Starch, Microcrystalline Cellulose,  Povidone, Silicone Dioxide, Sodium Starch Glycolate, Stearic Acid,


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EPHED PLUS SINUS  
acetaminophen, pseudoephedrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65193-144
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (white) Score4 pieces
ShapeROUND (EP350) Size12mm
FlavorImprint Code EP530
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65193-144-462 in 1 BLISTER PACK; Type 0: Not a Combination Product10/18/201111/14/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/18/201111/14/2018
Labeler - Dickey Consumer Products DBA DMD (835974056)
Registrant - Dickey Consumer Products DBA DMD (835974056)
Establishment
NameAddressID/FEIBusiness Operations
Ultratab Laboratories, Inc.151051757manufacture(65193-144)

Revised: 11/2018
 
Dickey Consumer Products DBA DMD