NASAL DECONGESTANT- pseudoephedrine hydrochloride capsule, gelatin coated

nasal decongestant by

Drug Labeling and Warnings

nasal decongestant by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

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 exceed recommended dosage

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occurs
• symptoms do not improve within 7 days or occur with a 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 softgels every 4 to 6 hours
  • do not take more than 8 softgels in 24 hours
• children ages 6 to under 12 years:
  • take 1 softgel every 4 to 6 hours
  • do not take more than 4 softgels in 24 hours
• children under 6 years:

  do not use this product in children under 6 years of age

Other information

• store at 20-25°C (68-77°F)
• do not use if blister unit is broken or torn

Inactive ingredients

croscarmellose sodium, FD&C red no. 40, gelatin, guar gum, hydroxypropylcellulose, lecithin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, purified water, sorbitan, sorbitol, titanium dioxide, vegetable oil, xanthan gum

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Non-Drowsy

Nasal Decongestant

MAXIMUM STRENGTH

PSEUDOEPHEDRINE HCl

Nasal decongestant

Relieves:

Nasal & sinus congestion

Sinus pressure

Actual Size

24 SOFTGELS 30 mg EACH

INGREDIENTS AND APPEARANCE

NASAL DECONGESTANT 
pseudoephedrine hydrochloride capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-189
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GUAR GUM (UNII: E89I1637KE)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	PT3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-189-62	24 in 1 CARTON	02/09/2017
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 69842-189-67	48 in 1 CARTON	07/20/2017
2		1 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	02/09/2017

Labeler - CVS Pharmacy (062312574)