12 HOUR DECONGESTANT- pseudoephedrine hydrochloride tablet, film coated, extended release

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)
Available from:
Kroger Company
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Nasal decongestant
Authorization status:
Abbreviated New Drug Application
Authorization number:
30142-054-60

12 HOUR DECONGESTANT- pseudoephedrine hydrochloride tablet, film coated, extended

release

Kroger Company

----------

Kroger Co. 12 Hour Decongestant Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 120 mg

Purpos e

Nasal decongestant

Us es

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

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

temporarily relieves nasal congestion due to the common cold, hay fever or other upper

respiratory allergies

temporarily relieves sinus congestion and pressure

heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to an enlarged prostate gland

nervousness, dizziness, or sleeplessness occur

symptoms do not improve within 7 days or occur with a fever

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

children under 12 years

do not use this product in children under 12 years of age

Other information

Inactive ingredients

carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose,

magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of SUDAFED® SINUS CONGESTION 12 HOUR CAPLETS

See back panel

NON-DROWSY

SINUS

12 Hour Decongestant

Pseudoephedrine Hydrochloride Extended Release Tablets, 120 mg

Nasal Decongestant

MAXIMUM STRENGTH

Sinus Pressure

Congestion

Our Pharmacists Recommend

20 COATED CAPLETS* 120 mg EACH

*Capsule-Shaped Tablets

actual size

take 1 tablet every 12 hours

do not take more than 2 tablets in 24 hours

each tablet contains: calcium 45 mg

store at 20-25°C (68-77°F) in a dry place

protect from light

do not use if blister unit is broken or torn

see carton end panel for lot number and expiration date

this product meets the requirements of USP Drug Release Test 3

12 HOUR DECONGESTANT

pseudoephedrine hydrochloride tablet, film coated, extended release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:30 142-0 54

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PSEUDO EPHEDRINE HYDRO CHLO RIDE (UNII: 6 V9 V2RYJ8 N) (PSEUDOEPHEDRINE

- UNII:7CUC9 DDI9 F)

PSEUDOEPHEDRINE

HYDROCHLORIDE

120 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CARNAUBA WAX (UNII: R12CBM0 EIZ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

DIBASIC CALCIUM PHO SPHATE DIHYDRATE (UNII: O7TSZ9 7GEP)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

OVAL

S iz e

18 mm

Flavor

Imprint Code

L0 54

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:30 142-0 54-6 0

20 in 1 CARTON

0 3/11/20 0 4

1

1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 75153

12/14/19 9 9

Kroger Company

Labeler -

Kroger Company (006999528)

Revised: 5/2019

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