PSEUDOEPHEDRINE HYDROCHLORIDE tablet

Pseudoephedrine Hydrochloride by

Drug Labeling and Warnings

Pseudoephedrine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCI 30 mg

PURPOSE

Purpose

Nasal Decongestant

Uses

• temporarily relieves sinus congestion and pressure 
• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

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 occur 
• 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 of age and over:
  • take 2 tablets every 4 to 6 hours
  • do not take more than 8 tablets in 24 hours
• children 6 to 11 years of age:
  • take 1 tablet every 4 to 6 hours 
  • do not take more than 4 tablets in 24 hours
• children under 6 years of age:
  • do not use this product in children under 6 years of age

Other Information

• store at 20ºC-25ºC (68º-77ºF)
• do not use if blister is broken or torn

INACTIVE INGREDIENT

Calcium sulfate, carnauba wax, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silica, stearic acid, sugar, titanium dioxide

Questions or comments?

1-800-231-4670

SPL UNCLASSIFIED SECTION

Important: Read all product information before using this box for important information.

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Sudafed® Congestion.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2018 CVS/pharmacy CVS.com®

1-800-SHOP CVS V-34602

PRINCIPAL DISPLAY PANEL

CVS Health TM

Compare to the active ingredient in Sudafed® Congestion*

Non-Drowsy

Nasal Decongestant

Pseudoephedrine Hydrochloride

Nasal decongestant

Maximum Strength

Relieves:

Nasal & sinus congestion

Sinus pressure

96 Tablets 30mg Each

INGREDIENTS AND APPEARANCE

PSEUDOEPHEDRINE HYDROCHLORIDE 
pseudoephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-204
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
SHELLAC (UNII: 46N107B71O)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
KAOLIN (UNII: 24H4NWX5CO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
CARNAUBA WAX (UNII: R12CBM0EIZ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	1004
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-204-62	1 in 1 CARTON	06/28/2018
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 69842-204-67	2 in 1 CARTON	06/28/2018
2		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 69842-204-80	4 in 1 CARTON	06/28/2018
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	06/28/2018

Labeler - CVS Pharmacy, Inc. (062312574)