Topcare 44-462

Topcare 44-462
SPL v6
SPL
SPL Set ID 2a80fba9-5e30-4ec0-bd8e-8957c0654b6c
Route
ORAL
Published
Effective Date 2025-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (4 mg) Phenylephrine (10 mg)
Inactive Ingredients
Croscarmellose Sodium Anhydrous Lactose Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 44;462 Shape: round Color: white Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-02

Description

Chlorpheniramine maleate 4 mg Phenylephrine HCl 10 mg

Purpose

Antihistamine Nasal decongestant


Medication Information

Purpose

Antihistamine

Nasal decongestant

Description

Chlorpheniramine maleate 4 mg Phenylephrine HCl 10 mg

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

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

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.

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 Ingredients

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

Questions Or Comments?

1-888-423-0139

Principal Display Panel

+TopCare®

health

NDC 36800-642-08

MAXIMUM STRENGTH

Sinus & Allergy Relief PE

CHLORPHENIRAMINE MALEATE 4 mg - ANTIHISTAMINE

PHENYLEPHRINE HCl 10 mg - NASAL DECONGESTANT

RELIEVES:

• Sneezing                  • Sinus Congestion & Pressure

• Runny Nose             • Itching of the Nose or Throat

• Nasal Congestion    • Itchy, Watery Eyes

24 TABLETS

actual size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT

IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO LNKA0621

QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

50844    ORG031946208

QUALITY GUARANTEED

This TopCare® product is laboratory

tested to guarantee its highest quality.

Your total satisfaction is guaranteed.

TopCare 44-462
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.

Active Ingredients (in Each Tablet)

Chlorpheniramine maleate 4 mg

Phenylephrine HCl 10 mg

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.


Structured Label Content

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

Purpose

Antihistamine

Nasal decongestant

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

Do Not Use (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.

Other Information (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 Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-888-423-0139

Principal Display Panel (Principal display panel)

+TopCare®

health

NDC 36800-642-08

MAXIMUM STRENGTH

Sinus & Allergy Relief PE

CHLORPHENIRAMINE MALEATE 4 mg - ANTIHISTAMINE

PHENYLEPHRINE HCl 10 mg - NASAL DECONGESTANT

RELIEVES:

• Sneezing                  • Sinus Congestion & Pressure

• Runny Nose             • Itching of the Nose or Throat

• Nasal Congestion    • Itchy, Watery Eyes

24 TABLETS

actual size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT

IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO LNKA0621

QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

50844    ORG031946208

QUALITY GUARANTEED

This TopCare® product is laboratory

tested to guarantee its highest quality.

Your total satisfaction is guaranteed.

TopCare 44-462
When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Chlorpheniramine maleate 4 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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