Generic Name: guaifenesin
Dosage Form: tablet, extended release

Mucinex®

Drug Facts

Active ingredient (in each extended-release bi-layer tablet)

Guaifenesin 600 mg

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Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Do not use

  • for children under 12 years of age

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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

  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
  • children under 12 years of age: do not use

Other information

  • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
  • store between 20-25°C (68-77°F)

Inactive ingredients

carbomer 934P, NF; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Distributed by:
Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224
©RBI 2009

PRINCIPAL DISPLAY PANEL - 600 mg Tablet Carton

NDC 63824-008-32

Mucinex®
600 mg guaifenesin extended-release bi-layer tablets

EXPECTORANT

12
HOUR

NEW LOOK –
SAME RELIEF

Thins And Loosens Mucus
Relieves Chest Congestion

20 EXTENDED-RELEASE BI-LAYER TABLETS

Mucinex 
guaifenesin tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-008
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Guaifenesin (Guaifenesin) Guaifenesin 600 mg
Product Characteristics
Color WHITE (blue and white) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code Mucinex;600
Contains         
Packaging
# Item Code Package Description
1 NDC:63824-008-32 2 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 10 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
2 NDC:63824-008-34 4 BLISTER PACK (BLISTER PACK) in 1 CARTON
2 10 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
3 NDC:63824-008-10 1 BOTTLE (BOTTLE) in 1 CARTON
3 100 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE
4 NDC:63824-008-50 1 BOTTLE (BOTTLE) in 1 CARTON
4 500 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE
5 NDC:63824-008-61 1 BOTTLE (BOTTLE) in 1 BLISTER PACK
5 60 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE
6 NDC:63824-008-72 25 POUCH (POUCH) in 1 CARTON
6 2 TABLET, EXTENDED RELEASE (TABLET) in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021282 03/27/2009
Labeler - Reckitt Benckiser, Inc. (094405024)
Revised: 12/2009
 
Reckitt Benckiser, Inc.



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