Leader 12hr Allergy And Congestion Relief
fexofenadine hydrochloride, pseudoephedrine hydrochloride · Tablet, Film Coated, Extended Release · Oral
Active ingredient
Active ingredients (in each tablet) Fexofenadine HCl 60 mg Pseudoephedrine HCl 120 mg
Purpose
Purpose Antihistamine Nasal decongestant
Uses
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
Warnings
Warnings 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).
Do not use
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
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
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
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
Pregnancy 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 (1-800-222-1222).
Directions
Directions
• 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
Inactive ingredients
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?
Questions or comments? 1-800-719-9260
Label text from the FDA structured product label by Cardinal Health 110, LLC. dba Leader (revised Aug 3, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Fexofenadine Hydrochloride in 1 product
- Pseudoephedrine Hydrochloride in 1 product
Leader 12hr Allergy And Congestion Relief NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 70000-0772 | Fexofenadine Hydrochloride 60 mg/1; Pseudoephedrine Hydrochloride 120 mg/1 Tablet, Film Coated, Extended Release | Cardinal Health 110, LLC. dba Leader | ANDA |
Frequently asked questions
What is Leader 12hr Allergy And Congestion Relief used for?
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…
Who makes Leader 12hr Allergy And Congestion Relief?
Leader 12hr Allergy And Congestion Relief is listed by 1 labeler in the FDA NDC directory, including Cardinal Health 110, LLC. dba Leader.