Rugby Laboratories Allergy Relief D Drug Facts

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl 60 mg

Pseudoephedrine HCl 120 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• reduces swelling of nasal passages
• temporarily relieves sinus congestion and pressure
• temporarily restores freer breathing through the nose

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

• if you have ever had an allergic reaction to this product or any of its ingredients
• 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.
• if you have difficulty swallowing

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• heart disease
• thyroid disease
• glaucoma
• high blood pressure
• diabetes
• trouble urinating due to an enlarged prostate gland
• kidney disease. Your doctor should determine if you need a different dose.

When using this product

OTC - WHEN USING SECTION

• do not take more than directed
• do not take at the same time as aluminum or magnesium antacids
• do not take with fruit juices (see Directions)
• the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).

Stop use and ask a doctor if

OTC - STOP USE SECTION

• an allergic reaction to this product occurs. Seek medical help right away.
• symptoms do not improve within 7 days or are accompanied by a fever
• you get nervous, dizzy, or sleepless

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 right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

• do not divide, crush, chew or dissolve the tablet; swallow tablet whole

adults and children 12 years of age and over	take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours
children under 12 years of age	do not use
adults 65 years of age and older	ask a doctor
consumers with kidney disease	ask a doctor

Other information

OTHER SAFETY INFORMATION

• each tablet contains: calcium 21 mg
• safety sealed: do not use if carton is opened or if individual blister units are torn or opened
• store between 20° and 25°C (68° and 77°F)
• meets USP Dissolution Test 2

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby®

compare to the active ingredients in Allegra-D® Allergy & Congestion

non-drowsy

allergy relief D

fexofenadine HCl 60 mg and pseudoephedrine HCl 120 mg extended release tablets

antihistamine/nasal decongestant

12 HR

allergy & congestion

indoor/outdoor relief of

• nasal and sinus congestion due to colds or allergies

• sneezing; runny nose; itchy, watery eyes and itchy nose or throat due to allergies

20 extended release tablets

actual size

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

• RUGBY ALLERGY RELIEF D
• fexofenadine hydrochloride, pseudoephedrine hydrochloride
• FEXOFENADINE HYDROCHLORIDE
• FEXOFENADINE
• PSEUDOEPHEDRINE HYDROCHLORIDE
• PSEUDOEPHEDRINE
• SILICON DIOXIDE
• CROSCARMELLOSE SODIUM
• D&C YELLOW NO. 10 ALUMINUM LAKE
• DIBASIC CALCIUM PHOSPHATE DIHYDRATE
• FD&C BLUE NO. 2 ALUMINUM LAKE
• FD&C YELLOW NO. 6 ALUMINUM LAKE
• HYPROMELLOSE, UNSPECIFIED
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• POLYETHYLENE GLYCOL, UNSPECIFIED

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Orange Book application contexts#

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Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

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Observed Orange Book product history#

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openFDA label cross-check#

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Reported adverse events (FAERS/openFDA)#

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