Your browser does not support JavaScript! MUCINEX ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET [RECKITT BENCKISER LLC]
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RxNorm Names

MUCINEX ALLERGY (fexofenadine hydrochloride) tablet
[Reckitt Benckiser LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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 overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask 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

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

Principal Display Panel - 180 mg Blister Pack Carton
MUCINEX   ALLERGY
fexofenadine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63824-926
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fexofenadine Hydrochloride (Fexofenadine) Fexofenadine Hydrochloride180 mg
Inactive Ingredients
Ingredient NameStrength
silicon dioxide 
starch, corn 
croscarmellose sodium 
FD&C Red no. 40 
hypromelloses 
ferrosoferric oxide 
magnesium stearate 
mannitol 
polyethylene glycols 
powdered cellulose 
titanium dioxide 
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize7mm
FlavorImprint Code 194;R
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-926-051 in 1 CARTON
15 in 1 BLISTER PACK
2NDC:63824-926-101 in 1 CARTON
210 in 1 BLISTER PACK
3NDC:63824-926-303 in 1 CARTON
310 in 1 BLISTER PACK
4NDC:63824-926-404 in 1 CARTON
410 in 1 BLISTER PACK
5NDC:63824-926-802 in 1 CARTON
5NDC:63824-926-404 in 1 CARTON
510 in 1 BLISTER PACK
6NDC:63824-926-606 in 1 CARTON
610 in 1 BLISTER PACK
7NDC:63824-926-888 in 1 CARTON
710 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07650201/02/2014
Labeler - Reckitt Benckiser LLC (094405024)

Revised: 4/2014
 
Reckitt Benckiser LLC

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