MedPath

Sinus PE and Allergy

Equate 44-462

Approved
Approval ID

05fefc08-268f-4e8e-8c3a-555936a72730

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 16, 2025

Manufacturers
FDA

WALMART INC.

DUNS: 051957769

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Chlorpheniramine Maleate, Phenylephrine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code79903-075
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Chlorpheniramine Maleate, Phenylephrine HCl
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 16, 2025
FDA Product Classification

INGREDIENTS (8)

CHLORPHENIRAMINE MALEATEActive
Quantity: 4 mg in 1 1
Code: V1Q0O9OJ9Z
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 04JA59TNSJ
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/16/2025

Principal display panel

equate™

NDC 79903-075-08

Sinus PE & Allergy
****Chlorpheniramine Maleate and Phenylephrine HCl
Antihistamine, Nasal Decongestant

MAXIMUM STRENGTH

Relieves:

• Sneezing, runny nose, nasal congestion
• Sinus congestion & pressure
• Itching of the nose or throat
• Itchy, watery eyes

Actual Size

24
****TABLETS

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 or to report an undesired reaction
or side effect, please call1-888-287-1915.

DISTRIBUTED BY:
** Walmart Inc.,**
** Bentonville, AR 72716**

50844 ORG031946208

Equate 44-462

Equate 44-462

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/16/2025

Uses

  • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

    • itchy, watery eyes

    • runny nose

    • itching of the nose or throat

    • nasal congestion

    • sneezing

    • sinus congestion and pressure

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/16/2025

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg
Phenylephrine HCl 10 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/16/2025

Purpose

Antihistamine
Nasal decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 9/16/2025

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

  • difficulty in urination due to enlargement of the prostate gland

  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

*do not exceed recommended dosage

  • excitability may occur, especially in children

  • drowsiness may occur

  • avoid alcoholic beverages

  • alcohol, sedatives and tranquilizers may increase drowsiness

  • use caution 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 right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/16/2025

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/16/2025

Other information

*TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/16/2025

Inactive ingredients

croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/16/2025

Questions or comments?

1-888-287-1915

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Sinus PE and Allergy - FDA Drug Approval Details