Active ingredientFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure9 sections
Indications and uses
• 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...
Dosage and administration
• 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
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
Questions or comments?
OTC - QUESTIONS SECTION
Call 1-833-358-6431
Package/Label Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
COMPARE TO THE ACTIVE INGREDIENTS IN ALLEGRA-D® 12 HOUR ALLERGY & CONGESTION
Foster & Thrive®
Allergy & Congestion-D
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablets
60 mg/120 mg
ANTIHISTAMINE/NASAL DECONGESTANT
12 HR
Non-Drowsy
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
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