SUNMARK NASAL DECONGESTANT- pseudoephedrine hcl tablet, film coated

Sunmark Nasal Decongestant by

Drug Labeling and Warnings

Sunmark Nasal Decongestant by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

When using this product

do not use more than directed

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• symptoms do not get better 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. (1-800-222-1222)

Directions

• adults and children 12 years and over:
  • 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

• each tablet contains: calcium 20 mg
• store at 20°-25°C (68°-77°F)

Inactive ingredients

carnauba wax, dibasic calcium phosphate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Sudafed® Nasal Decongestant active ingredient

See New Dosing Directions

Nasal Decongestant

Maximum Strength

Nasal & Sinus Congestion

Sinus Pressure

Pseudoephedrine Hydrochloride

Gluten Free

Non-Drowsy

30 mg each

Nasal Decongestant Carton

Nasal Decongestant Carton

INGREDIENTS AND APPEARANCE

SUNMARK NASAL DECONGESTANT 
pseudoephedrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-024
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND (convex)	Size	7mm
Flavor		Imprint Code	L432
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-024-04	1 in 1 CARTON	08/15/2003
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 49348-024-08	2 in 1 CARTON	08/15/2003
2		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 49348-024-34	4 in 1 CARTON	08/15/2003
3		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/15/2003

Labeler - Strategic Sourcing Services LLC (116956644)