Suphedrine by CHAIN DRUG MARKETING ASSOCIATION INC / LNK International, Inc. QC 44-112-Delisted

Suphedrine by

Drug Labeling and Warnings

Suphedrine by is a Otc medication manufactured, distributed, or labeled by CHAIN DRUG MARKETING ASSOCIATION INC, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUPHEDRINE MAXIMUM STRENGTH- pseudoephedrine hcl tablet, film coated 
CHAIN DRUG MARKETING ASSOCIATION INC

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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QC 44-112-Delisted

Active ingredient  (in each tablet)

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant

Uses

  • 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 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

  • diabetes
  • heart disease
  • high blood pressure
  • 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 years		take 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 25ºC (77ºF); excursions permitted between 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?

Call 1-800-426-9391 8:30 AM-4:00PM ET, Monday-Friday

Principal Display Panel

NDC: 63868-146-48

*Compare to the
active ingredient in
SUDAFED® CONGESTION

QC
QUALITY
CHOICE®

Maximum Strength
Suphedrine
Nasal Decongestant
Pseudoephedrine HCl 30 mg | Non-Drowsy

Nasal & Sinus Congestion
Sinus Pressure

48 Tablets (30 mg Each)

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

*This product is not manufactured or distributed by
McNeil Consumer Healthcare, owner of the registered
trademark Sudafed® Congestion.
50844      REV0712A11222

©Distributed by C.D.M.A., Inc.
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
Questions: 248-449-9300

Quality Choice 44-112

Quality Choice 44-112

SUPHEDRINE  MAXIMUM STRENGTH
pseudoephedrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63868-146
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize7mm
FlavorImprint Code 44;112
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63868-146-241 in 1 CARTON08/25/198102/22/2020
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 63868-146-501 in 1 CARTON08/25/198111/22/2016
250 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 63868-146-222 in 1 CARTON08/25/198111/22/2016
324 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC: 63868-146-482 in 1 CARTON08/25/198102/22/2020
424 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/25/198102/22/2020
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(63868-146)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(63868-146)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(63868-146)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(63868-146)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(63868-146)

Revised: 11/2017
Document Id: b359be70-3b20-492b-bfae-3f04b506bf99
Set id: b407c167-1711-4455-8082-b56b22f5d379
Version: 13
Effective Time: 20171109
 
CHAIN DRUG MARKETING ASSOCIATION INC