Fexofenadine Hydrochloride Tablet [Spirit Pharmaceuticals Llc] -

FEXOFENADINE HYDROCHLORIDE TABLET [SPIRIT PHARMACEUTICALS LLC]
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Drug Facts
Active ingredient (in each tablet)

Fexofenadine HCl 180 mg
Purpose

Antihistamine
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
Warnings
DO NOT USE

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. You may report side effects to FDA at 1-800-FDA-1088.
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.

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

Drug Facts (continued)
OTHER SAFETY INFORMATION

Other information  safety sealed: do not use if printed foil inner
seal on bottle is torn or missing  store between 20º and 25ºC (68º
and 77ºF)  protect from excessive moisture
INACTIVE INGREDIENT

Inactive ingredients colloidal silicone dioxide, croscarmellose sodium, hypromellose,
magnesium stearate, microcrystalline cellulose, polyethylene
glycol/macrogol, povidone, pregelatinized starch, red iron oxide,
silica, titanium dioxide, yellow iron oxide.
QUESTIONS

Questions or comments? call +1-888-333-9792
SPL UNCLASSIFIED SECTION

Distributed by:
Spirit Pharmaceuticals LLC,
Ronkonkoma, NY 11779

ORG 03/19

Manufactured by:
Unique Pharmaceutical
Laboratories
(A Div. of J. B. Chemicals &
Pharmaceuticals Ltd.)
Mumbai 400 030, India
Mfg. Lic. No.: G/1430
PRINCIPAL DISPLAY PANEL

Valumeds™

NDC 68210-0122-1
non-drowsy
FEXOFENADINE
HYDROCHLORIDE
TABLETS USP
180 mg
antihistamine

24 Hour

indoor & outdoor allergy relief
• sneezing • runny nose
• itchy, watery eyes
• itchy nose or throat

100 tablets

Actual Size

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Ingredient Name	Strength
Inactive Ingredients
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68210-0122-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/22/2019
2	NDC:68210-0122-3	1 in 1 CARTON	09/18/2020
2		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA210137	03/21/2019

Labeler - Spirit Pharmaceuticals LLC (179621011)

Name	Address	ID/FEI	Business Operations
Establishment
Unique Pharmaceutical Laboratories		650434645	manufacture(68210-0122)

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