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NDC 49035-0354-23 Suphedrine PE 10 mg/1 Details

Suphedrine PE 10 mg/1

Suphedrine PE is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores Inc. The primary component is PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

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

Related Packages: 49035-0354-23
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	49035-0354
Product ID	49035-354_293b34a5-d7ab-4c46-b369-bfdb68ca86b2
Associated GPIs
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	Suphedrine PE
Proprietary Name Suffix	n/a
Non-Proprietary Name	Phenylephrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Wal-Mart Stores Inc
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	n/a

Package

Package Images

NDC 49035-0354-23 (49035035423)

Pricing Information	N/A
NDC Package Code	49035-354-23
Billing NDC	49035035423
Package	3 BLISTER PACK in 1 CARTON (49035-354-23) / 24 TABLET, FILM COATED in 1 BLISTER PACK (49035-354-43)
Marketing Start Date	2005-01-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8f8d9f9e-6277-4184-b22b-004c3e6d975d Details

Active ingredient (in each tablet)

Phenylephrine HCl 10 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

diabetes
heart disease
high blood pressure
thyroid disease
difficulty in urination due to enlargement of the 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 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.

Directions

adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
children under 12 years: ask a doctor

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Questions or comments?

1-888-287-1915

Principal display panel

NDC 49035-354-23

equate™

Compare to Sudafed PE® Congestion Active Ingredient*

Congestion

Suphedrine PE

Phenylephrine HCl Tablets,10 mg

Nasal Decongestant

Non-Drowsy

Relieves:

• Sinus Pressure

• Congestion

Maximum Strength

10 mg EACH 72 TABLETS

Actual Size

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Sudafed PE® Congestion.

50844 REV0118B45323

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments nor to report an undesired reaction or side effect, please call 1-888-287-1915.

44-453

INGREDIENTS AND APPEARANCE

SUPHEDRINE PE

phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-354
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	44;453
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-354-23	3 in 1 CARTON	01/14/2005	11/24/2023
1	NDC:49035-354-43	24 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	01/14/2005	11/24/2023

Labeler - Wal-Mart Stores Inc (051957769)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(49035-354)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(49035-354)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(49035-354)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(49035-354)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(49035-354)

Revised: 8/2022

Document Id: 293b34a5-d7ab-4c46-b369-bfdb68ca86b2

Set id: 8f8d9f9e-6277-4184-b22b-004c3e6d975d

Version: 10

Effective Time: 20220810