Foster And Thrive Allergy And Congestion D Tablet, Film Coated, Extended Release
FDA Label NDC 70677-1315

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Foster And Thrive Allergy And Congestion D (NDC 70677-1315). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Tablet)

Fexofenadine HCl 60 mg

Pseudoephedrine HCl 120 mg

Purpose

Antihistamine

Nasal decongestant

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 the nose

Do Not Use

  • 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

  • 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

  • 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

  • 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,

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 (1-800-222-1222).

Directions

  • do not divide, crush, chew or dissolve the tablet; swallow tablet whole
    • adults and children 12 years of age and overtake 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hourschildren under 12 years of agedo not useadults 65 years of age and olderask a doctorconsumers with kidney diseaseask a doctor
     
     
     
     
     
     
     
     

Other 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

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?

Call 1-833-358-6431

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

ACTUAL SIZE

30 EXTENDED RELEASE TABLETS

Foster&thrive-allergy-&-congestion-d-carton-image.jpg (Image 01)

Foster&thrive-allergy-&-congestion-d-carton-image.jpg (Image 01)

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