DrugInserts.com: Trustworthy FDA Drug Information

Over the Counter Medications

Package Insert and Label Information: Mucinex

By Reckitt Benckiser LLC | Last revised: 28 December 2012

MUCINEX- guaifenesin tablet, extended release
Reckitt Benckiser LLC

Drug Facts

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

Guaifenesin 600 mg

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 homopolymer type B; 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
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL — 60 Tablet Carton

NDC 63824-008-69

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

12 HOUR

✔
Relieves Chest Congestion
✔
Thins And Loosens Mucus

60 extended-release bi-layer tablets

Principal Display Panel -- 60 Tablet Carton
(click image for full-size original)
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
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE B
FD&C BLUE NO. 1
ALUMINUM OXIDE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
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 Multilevel Packaging
1 NDC:63824-008-32 2 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 10 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (63824-008-32)
2 NDC:63824-008-34 4 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
2 10 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (63824-008-34)
3 NDC:63824-008-10 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
3 100 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE This package is contained within the CARTON (63824-008-10)
4 NDC:63824-008-50 500 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
5 NDC:63824-008-61 1 BOTTLE (BOTTLE) in 1 BLISTER PACK contains a BOTTLE
5 60 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE This package is contained within the BLISTER PACK (63824-008-61)
6 NDC:63824-008-72 25 POUCH (POUCH) in 1 CARTON contains a POUCH
6 2 TABLET, EXTENDED RELEASE (TABLET) in 1 POUCH This package is contained within the CARTON (63824-008-72)
7 NDC:63824-008-36 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
7 6 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE This package is contained within the CARTON (63824-008-36)
8 NDC:63824-008-62 1 BOTTLE (BOTTLE) in 1 BLISTER PACK contains a BOTTLE
8 65 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE This package is contained within the BLISTER PACK (63824-008-62)
9 NDC:63824-008-12 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
9 115 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE This package is contained within the CARTON (63824-008-12)
10 NDC:63824-008-69 3 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
10 20 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (63824-008-69)
11 NDC:63824-008-27 4 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
11 18 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (63824-008-27)
12 NDC:63824-008-15 5 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
12 20 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (63824-008-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021282 07/22/2010
Labeler — Reckitt Benckiser LLC (094405024)

Revised: 12/2012 Reckitt Benckiser LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

The URL of this page is:
http://druginserts.com/lib/otc/meds/mucinex-5/