MUCINEX ALLERGY- fexofenadine hydrochloride tablet

Mucinex by

Drug Labeling and Warnings

Mucinex by is a Otc medication manufactured, distributed, or labeled by Reckitt Benckiser LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• itchy, watery eyes
• sneezing
• itching of the nose or throat

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have 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)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

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.

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

Other information

• 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)
• protect from excessive moisture
• this product meets the requirements of USP Dissolution Test 2

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide

Questions?

Call 1-855-419-9622

SPL UNCLASSIFIED SECTION

Dist. By Reckitt Benckiser
Parsippany, NJ 07054-0224
Made in India

PRINCIPAL DISPLAY PANEL - 180 mg Blister Pack Carton

NEW

NDC: 63824-926-10

NON-DROWSY
Mucinex®
ALLERGY

Fexofenadine Hydrochloride Tablets USP, 180 mg/Antihistamine

INDOOR & OUTDOOR ALLERGY RELIEF

24hr

ORIGINAL
PRESCRIPTION STRENGTH

✓ Sneezing
✓ Runny Nose
✓ Itchy, Watery Eyes
✓ Itchy Nose or Throat

10 TABLETS 180 mg each

INGREDIENTS AND APPEARANCE

MUCINEX   ALLERGY
fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-926
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
silicon dioxide (UNII: ETJ7Z6XBU4)
starch, corn (UNII: O8232NY3SJ)
croscarmellose sodium (UNII: M28OL1HH48)
FD&C Red no. 40 (UNII: WZB9127XOA)
hypromelloses (UNII: 3NXW29V3WO)
ferrosoferric oxide (UNII: XM0M87F357)
magnesium stearate (UNII: 70097M6I30)
mannitol (UNII: 3OWL53L36A)
polyethylene glycols (UNII: 3WJQ0SDW1A)
powdered cellulose (UNII: SMD1X3XO9M)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	7mm
Flavor		Imprint Code	194;R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-926-05	1 in 1 CARTON
1		5 in 1 BLISTER PACK
2	NDC: 63824-926-10	1 in 1 CARTON
2		10 in 1 BLISTER PACK
3	NDC: 63824-926-30	3 in 1 CARTON
3		10 in 1 BLISTER PACK
4	NDC: 63824-926-40	4 in 1 CARTON
4		10 in 1 BLISTER PACK
5	NDC: 63824-926-80	2 in 1 CARTON
5	NDC: 63824-926-40	4 in 1 CARTON
5		10 in 1 BLISTER PACK
6	NDC: 63824-926-60	6 in 1 CARTON
6		10 in 1 BLISTER PACK
7	NDC: 63824-926-88	8 in 1 CARTON
7		10 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076502	01/02/2014

Labeler - Reckitt Benckiser LLC (094405024)