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 years	do 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

SUPHEDRINE MAXIMUM STRENGTH
pseudoephedrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-146
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	RED	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	44;112
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-146-24	1 in 1 CARTON	08/25/1981	02/22/2020
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:63868-146-50	1 in 1 CARTON	08/25/1981	11/22/2016
2		50 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:63868-146-22	2 in 1 CARTON	08/25/1981	11/22/2016
3		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:63868-146-48	2 in 1 CARTON	08/25/1981	02/22/2020
4		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	08/25/1981	02/22/2020

Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(63868-146)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(63868-146)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(63868-146)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(63868-146)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(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