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Maximum Strength Suphedrine

Dosage form: tablet
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 30mg
Labeler: CHAIN DRUG MARKETING ASSOCIATION INC
NDC Code: 63868-146

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.

Quality Choice 44-112

Active ingredient Pseudoephedrine HCl 30 mg

Purpose Nasal Congestant

Use(s)
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • 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 2 weeks after stoppin 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
  • diabetes
  • high blood pressure
  • heart disease
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

When using this product
  • do not exceed recommended dose

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with fever

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
adults and children
12 years and older 		take 2 tablets every 4 to 6 hours;
do not take more than 8 tablets in
24 hours 
children ages 6 to 12 yearstake 1 tablet every 4 to 6 hours;
do not take more than 4 tablets in
24 hours 
children under 6 yearsdo not use this product in children
under 6 years of age 

Other information
  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients croscarmellose sodium, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin

Questions or comments? 1-800-426-9391

Principal Display Panel

NDC 63868-146-24

Compare to the active ingredient in Sudafed®*

QC

QUALITY CHOICE®

MAXIMUM STRENGTH

SUPHEDRINE

SINUS CONGESTION

PSEUDOEPHEDRINE HCl 30 mg

NON-DROWSY

SINUS PRESSURE

CONGESTION

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OF SHOWS ANY SIGNS OF TAMPERING

50844     ORG031011208

©DISTRIBUTED BY QUALITY CHOICE

NOVI, MI 48376-0995

QC 90133

Product Packaging

MAXIMUM STRENGTH SUPHEDRINE 
pseudoephedrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-146
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 44;112
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-146-241 BLISTER PACK (1 CARTON) in 1 CARTON
124 TABLET (24 TABLET) in 1 BLISTER PACK
2NDC:63868-146-501 BLISTER PACK (1 BLISTER PACK) in 1 CARTON
250 TABLET (50 TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/25/1981
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

Revised: 02/2012
Document Id: ee8afa9f-f066-477f-aa2c-ce696d07b733
Set id: b407c167-1711-4455-8082-b56b22f5d379
Version: 9
Effective Time: 20120215
 
CHAIN DRUG MARKETING ASSOCIATION INC

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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