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NDC 49035-0462-08 Suphedrine PE 4; 10 mg/1; mg/1 Details

Suphedrine PE 4; 10 mg/1; mg/1

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

MedlinePlus Drug Summary

Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 49035-0462-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlorpheniramine

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: 49035-0462-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	49035-0462
Product ID	49035-462_6a623410-2646-4055-a28c-0bc3af261b68
Associated GPIs	43993002300315
GCN Sequence Number	059701
GCN Sequence Number Description	chlorpheniramine/phenylephrine TABLET 4MG-10MG ORAL
HIC3	Z2N
HIC3 Description	1ST GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION
GCN	25462
HICL Sequence Number	000446
HICL Sequence Number Description	CHLORPHENIRAMINE MALEATE/PHENYLEPHRINE HCL
Brand/Generic	Generic
Proprietary Name	Suphedrine PE
Proprietary Name Suffix	n/a
Non-Proprietary Name	Chlorpheniramine maleate and Phenylephrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	4; 10
Active Ingredient Units	mg/1; mg/1
Substance Name	CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Wal-Mart Stores Inc
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 49035-0462-08 (49035046208)

Pricing Information	N/A
NDC Package Code	49035-462-08
Billing NDC	49035046208
Package	1 BLISTER PACK in 1 CARTON (49035-462-08) / 24 TABLET in 1 BLISTER PACK (49035-462-43)
Marketing Start Date	2005-06-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 47641a71-feec-4c9f-972b-15c22f8df736 Details

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg

Phenylephrine HCl 10 mg

Purpose

Antihistamine

Nasal decongestant

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- sinus congestion and pressure
- nasal congestion

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

high blood pressure
heart disease
thyroid disease
diabetes
glaucoma
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

do not exceed recommended dose
excitability may occur, especially in children
drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

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 (1-800-222-1222) 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: do not use this product in children under 12 years of age

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, silica gel, stearic acid

Questions or comments?

1-888-287-1915

Principal display panel

equate™

NDC 49035-462-08

Compare to

Sudafed PE®

Sinus + Allergy

Active

Ingredients*

Sinus & Allergy

Suphedrine PE

Chlorpheniramine maleate and Phenylephrine HCl

Antihistamine, Nasal Decongestant

Relieves:

• Sinus pressure & congestion

• Sneezing, itchy eyes & runny nose

Maximum Strength

24

TABLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR

IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS

OF TAMPERING

Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716

*This product is not manufactured or distributed by McNeil Consumer Healthcare,

owner of the registered trademark Sudafed PE® Sinus + Allergy.

50844 ORG061246208

Satisfaction guaranteed -

Or we'll replace it or give you

your money back. For questions

or comments or to report an

undesired reaction or side effect,

please call 1-800-287-1915.

Equate 44-462

INGREDIENTS AND APPEARANCE

SUPHEDRINE PE

chlorpheniramine maleate and phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-462
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	44;462
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-462-08	1 in 1 CARTON	06/09/2005	10/01/2023
1	NDC:49035-462-43	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	06/09/2005	10/01/2023

Labeler - Wal-Mart Stores Inc (051957769)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(49035-462)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(49035-462)

Revised: 10/2021

Document Id: 6a623410-2646-4055-a28c-0bc3af261b68

Set id: 47641a71-feec-4c9f-972b-15c22f8df736

Version: 14

Effective Time: 20211004