Mucinex tablet, extended release

Spl unclassified section

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.

Otc - pregnancy or breast feeding section

If pregnant or breast-feeding,ask a health professional before use.

Otc - keep out of reach of children section

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

  • store between 20-25C (68-77F)

Inactive ingredients

carbomer homopolymer type B; FD&C blue no. 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.

Spl unclassified section

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

Made in England

How supplied

Product: 63629-7115

NDC: 63629-7115-1 30 TABLET, EXTENDED RELEASE in a BOTTLE

NDC: 63629-7115-2 20 TABLET, EXTENDED RELEASE in a BOTTLE

NDC: 63629-7115-3 60 TABLET, EXTENDED RELEASE in a BOTTLE

NDC: 63629-7115-4 40 TABLET, EXTENDED RELEASE in a BOTTLE

NDC: 63629-7115-5 14 TABLET, EXTENDED RELEASE in a BOTTLE

Ingredients and appearance - Product information

Mucinex tablet, extended release- Guaifenesin

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 63629-7115
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 600 mgin 1

Inactive Ingredients

Ingredient Name Code
Carbomer homopolymer type b (allyl pentaerythritol crosslinked) ( UNII: HHT01ZNK31)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Aluminum oxide ( UNII: LMI26O6933)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)

Product Characteristics

Color WHITE (blue and white) Score 1
Shape OVAL Size 16 mm
Imprint Code Mucinex;600

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 63629-7115-1 30 in 1 BOTTLE 2016/10/17
2 NDC: 63629-7115-2 20 in 1 BOTTLE 2016/10/17
3 NDC: 63629-7115-3 60 in 1 BOTTLE 2016/10/17
4 NDC: 63629-7115-4 40 in 1 BOTTLE 2016/10/17
5 NDC: 63629-7115-5 14 in 1 BOTTLE 2016/10/17

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA021282 USA 2016/10/17

Labeler - Bryant Ranch Prepack( 171714327)

Establishment

Name ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK( 63629-7115), RELABEL( 63629-7115)

Guaifenesin