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NDC 00113-2008-62 sinus congestion 30 mg/1 Details

sinus congestion 30 mg/1

sinus congestion is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by L. Perrigo Company. The primary component is PSEUDOEPHEDRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.

Related Packages: 00113-2008-62
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	00113-2008
Product ID	0113-2008_84ba172c-07a9-4153-8e4a-c2027bda8dc9
Associated GPIs	42101020100305
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	sinus congestion
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pseudoephedrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	30
Active Ingredient Units	mg/1
Substance Name	PSEUDOEPHEDRINE HYDROCHLORIDE
Labeler Name	L. Perrigo Company
Pharmaceutical Class	Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00113-2008-62 (00113200862)

Pricing Information	N/A
NDC Package Code	0113-2008-62
Billing NDC	00113200862
Package	12 BLISTER PACK in 1 CARTON (0113-2008-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2016-10-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2dd0e007-4aeb-4b51-815e-4ebe378a4095 Details

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

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 and over	• take 2 tablets every 4 to 6 hours • do not take more than 8 tablets in 24 hours
children ages 6 to 11 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)
•: do not use if blister unit is broken or torn

Inactive ingredients

carnauba wax, dibasic calcium phosphate dihydrate, 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® Congestion active ingredient

MAXIMUM STRENGTH

sinus congestion

Pseudoephedrine HCl Tablets

Nasal Decongestant

CONGESTION

Sinus Pressure + Congestion

Non-Drowsy

Actual Size

96 TABLETS

(30 mg each)

INGREDIENTS AND APPEARANCE

SINUS CONGESTION

pseudoephedrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0113-2008
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0113-2008-80	48 in 1 CARTON	10/04/2016
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0113-2008-67	24 in 1 CARTON	10/04/2016
2		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0113-2008-62	12 in 1 CARTON	10/04/2016
3		2 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	10/04/2016

Labeler - L. Perrigo Company (006013346)

Revised: 12/2019

Document Id: 84ba172c-07a9-4153-8e4a-c2027bda8dc9

Set id: 2dd0e007-4aeb-4b51-815e-4ebe378a4095

Version: 3

Effective Time: 20191210