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Mucinex Maximum Strength

Pronunciation

Generic Name: guaifenesin
Dosage Form: tablet, extended release

MAXIMUM STRENGTH
Mucinex ®

Drug Facts

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

Guaifenesin 1200 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 tablet every 12 hours. Do not exceed 2 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

Questions?

1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

Dist. by: Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 1200 mg Tablet Carton

MAXIMUM STRENGTH

NDC 63824-023-36

Mucinex®
1200 mg guaifenesin extended-release bi-layer tablets

EXPECTORANT

12
HOUR

Thins And Loosens Mucus
Relieves Chest Congestion

28 EXTENDED-RELEASE BI-LAYER TABLETS

MUCINEX  MAXIMUM STRENGTH
guaifenesin tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-023
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Guaifenesin (Guaifenesin) Guaifenesin 1200 mg
Product Characteristics
Color WHITE (blue and white) Score no score
Shape OVAL Size 22mm
Flavor Imprint Code Mucinex;1200
Contains         
Packaging
# Item Code Package Description
1 NDC:63824-023-14 1 BOTTLE (BOTTLE) in 1 CARTON
1 14 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE
2 NDC:63824-023-36 4 BLISTER PACK (BLISTER PACK) in 1 CARTON
2 7 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
3 NDC:63824-023-28 1 BOTTLE (BOTTLE) in 1 CARTON
3 28 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE
4 NDC:63824-023-43 1 BOTTLE (BOTTLE) in 1 BLISTER PACK
4 42 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE
5 NDC:63824-023-45 1 BOTTLE (BOTTLE) in 1 BLISTER PACK
5 44 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021282 08/11/2009
Labeler - Reckitt Benckiser, Inc. (094405024)
Revised: 12/2009
 
Reckitt Benckiser, Inc.



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