FDA.reportPublic FDA data

Allergy Plus Congestion

Manufacturer
Topco Associates, LLC | LNK International, Inc.
Effective date
2019-04-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:25:26

Label at a glance#

ProductAllergy Plus Congestion
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

adults and children 12 years of age 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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg


Purpose

OTC - PURPOSE SECTION

Antihistamine
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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.
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms do not improve within 7 days or are accompanied by fever
  • nervousness, dizziness, or sleeplessness occur

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age 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

STORAGE AND HANDLING SECTION

  • 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 INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, stearic acid, titanium dioxide, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare®

NDC 36800-985-08

REGULAR STRENGTH

Allergy Plus
Sinus

DIPHENHYDRAMINE HCl
PHENYLEPHRINE HCl

ANTIHISTAMINE • NASAL DECONGESTANT

Relief of:

• Sneezing   • Itchy, Watery Eyes
• Runny Nose  • Itchy Throat
• Sinus Congestion   •Sinus Pressure
Easy to Swallow

QUALITY GUARANTEED 

COMPARE TO BENADRYL-D® ALLERGY PLUS SINUS active ingredients*

actual size

24 TABLETS

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl-D® Allergy Plus Sinus.

50844   ORG051248508

TopCare 44-485
TopCare 44-485

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800414341GTIN-13: 0036800414341
EAN-13: 0036800414341
GTIN-12: 036800414341
UPC-A: 036800414341
GTIN storage (14 digits): 00036800414341		topcare-44-485-1.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-98536800-985-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYDEXTROSEVH2XOU12IEIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
766e3ddf-d952-49a4-9342-2f72f292a69aa1767b69-bf64-4ae7-ab99-d687c9b71e2a2019-04-24WarningsExact identifier
spl id: 766e3ddf-d952-49a4-9342-2f72f292a69a
spl set id: a1767b69-bf64-4ae7-ab99-d687c9b71e2a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.