VALUMEDS NON-DROWSY ALLERGY RELIEF FEXOFENADINE HCL
FEXOFENADINE HYDROCHLORIDE · Cabinet Health P.B.C. · ORAL
Open FDA's page for this record- Set ID
- f9ccd673-c65f-45c6-9863-26136eb816db
- ID
- 5d559378-cddc-4b5b-e063-6394a90a42f2
- Effective time
- 20261008
- Version
- 3
- SPL product data elements
VALUMEDS NON-DROWSY ALLERGY RELIEF FEXOFENADINE HCL fexofenadine hydrochloride FEXOFENADINE HYDROCHLORIDE FEXOFENADINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED LIGHT MINERAL OIL MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 FERRIC OXIDE RED SODIUM STARCH GLYCOLATE TYPE A TALC TITANIUM DIOXIDE FERRIC OXIDE YELLOW j;44
- Active ingredient
- Fexofenadine
- Purpose
- Antihistamine
- Indications and usage
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ runny nose ■ itchy, watery eyes ■ sneezing ■ utching of the nose or throat
- Warnings
- Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients
- Ask doctor
- Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.
- When using
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)
- Stop use
- Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
- 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)
- Dosage and administration
Directions adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet 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
- Dosage and administration table
<table border="1"><tbody><tr><td><paragraph>adults and children 12 years of age and over</paragraph></td><td>take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours</td></tr><tr><td>children under 12 years of age</td><td>do not use</td></tr><tr><td>adults 65 years of age and older</td><td>ask a doctor</td></tr><tr><td>consumers with kidney disease</td><td>ask a doctor</td></tr></tbody></table>
- Other safety information
Other information ■ safety sealed: do not use if imprinted foil under bottle cap is opened or torn ■ store between 20° and 25°C (68° and 77°F) ■ protect from excessive moisture
- Inactive ingredient
Inactive ingredients colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide
- Questions
- Questions or comments? contact 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST
- Package label principal display panel
- Principle Packaging Display Panel PDP
- Harmonized identifiers (openFDA)
- Application number
- ANDA204097
- Brand name
- VALUMEDS NON-DROWSY ALLERGY RELIEF FEXOFENADINE HCL
- Generic name
- FEXOFENADINE HYDROCHLORIDE
- Manufacturer name
- Cabinet Health P.B.C.
- Product NDC
- 82725-1202
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Substance name
- FEXOFENADINE HYDROCHLORIDE
- RxCUI
- 997420
- SPL ID
- 5d559378-cddc-4b5b-e063-6394a90a42f2
- SPL set ID
- f9ccd673-c65f-45c6-9863-26136eb816db
- Package NDC
- 82725-1202-1, 82725-1202-2, 82725-1202-3
- Is original packager
- true
- Upc
- 5812062928087
- UNII
- 2S068B75ZU