Mucinex D

Name: Mucinex D

What should I avoid while taking guaifenesin and pseudoephedrine?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol with this medicine can cause side effects.

Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Guaifenesin and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug.

Guaifenesin and pseudoephedrine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using guaifenesin and pseudoephedrine and call your doctor at once if you have:

  • fast, pounding, or uneven heartbeat; or

  • severe anxiety or nervousness.

Common side effects may include:

  • dry mouth, nose, or throat;

  • upset stomach, loss of appetite, vomiting;

  • feeling excited or restless (especially in children);

  • sleep problems (insomnia); or

  • headache, dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly used brand name(s)

In the U.S.

  • Ala-Hist AC
  • Ala-Hist DHC
  • Alavert-D 12-Hour
  • Aldex D
  • Alka-Seltzer Plus Cold and Sinus
  • AllanVan-S
  • Allegra-D
  • Aller-Chlor
  • Allerx-D
  • Allfen CD
  • Allres PD
  • Amibid LA
  • Benadryl
  • BPM Pseudo
  • Bromcomp HC
  • Bromfed-PD
  • BroveX CB
  • By-Ache
  • Canges-HC
  • Ceron
  • Ceron-DM
  • Chlor-Trimeton Nasal Decongestant
  • Clarinex-D
  • Codimal DH
  • Cotab A
  • Cotabflu
  • Cypex-LA
  • Deconamine SR
  • Delsym
  • Dexphen w/C
  • Donatussin DC
  • Donnatussin
  • D-Tann HC
  • EndaCof-DC
  • FluTuss XP
  • Genapap Sinus
  • G Phen DM
  • HC Tussive
  • Histex PD
  • Humibid DM
  • Hycodan
  • Hycofenix
  • Hydone
  • HyTan
  • Kie
  • Levall 12
  • Lusonal
  • Maxiflu CD
  • Maxiphen CD
  • M-End Max D
  • Mucinex D
  • Nasop
  • Notuss-Forte
  • Notuss-NX
  • Notuss-NXD
  • Novahistine DH
  • Pancof HC
  • Pediatex 12
  • Pediatex 12D
  • Pediatex 12DM
  • Pediatex-D
  • Phenergan w/Codeine
  • Phenflu CD
  • Phenylephrine CM
  • Phenylhistine
  • Poly-Tussin AC
  • Poly-Tussin DHC
  • Pro-Clear AC
  • Promethazine VC With Codeine
  • Pro-Red AC
  • RelaTuss HC
  • Robitussin
  • Robitussin DM
  • Ryneze
  • Semprex-D
  • SSKI
  • Stahist
  • Sudafed
  • SymTan
  • SymTan A
  • Tanafed DMX
  • Tannate Pediatric
  • Tessalon Perles
  • Tricold Pediatric Drops
  • Tripohist D
  • Tussi-12 S
  • TussiCaps
  • Tuzistra XR
  • Tylenol
  • Uni-Tann D
  • Vituz
  • Xpect-PE
  • Y-Cof DM
  • Z-COF DM
  • Zhist
  • Zodryl DAC 25
  • Zotex-D
  • Zymine
  • Zymine HC
  • ZyrTEC-D

In Canada

  • Actifed A
  • Actifed Plus
  • Actifed Plus Extra Strength
  • Actifed Plus Head Cold And Sinus Extra Strength
  • Actifed Sinus Regular
  • Adult Nighttime Cold/Flu Relief - Cherry Flavor
  • Adult Nighttime Cold/Flu Relief - Original Flavor
  • Allergy Sinus Medication Extra Strength
  • Atoma Night Adult Cold/Flu Relief
  • Balminil
  • Balminil Dm Children
  • Balminil Dm Sugar-Free

Available Dosage Forms:

  • Suspension
  • Tablet, Disintegrating
  • Tablet, Chewable
  • Solution
  • Tablet
  • Syrup
  • Suspension, Extended Release
  • Tablet, Extended Release
  • Elixir
  • Liquid
  • Capsule, Extended Release
  • Capsule
  • Capsule, Liquid Filled
  • Capsule, Extended Release, 12 HR
  • Packet
  • Tablet, Extended Release, 12 HR
  • Film
  • Tablet, Effervescent
  • Powder for Suspension
  • Powder for Solution
  • Kit
  • Tablet, Extended Release, 24 HR
  • Capsule, Extended Release, 24 HR
  • Tablet, Enteric Coated

Other information

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

Inactive ingredients

carbomer 934P, NF; FD&C yellow #6 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 Carton

NDC 63824-057-18

Mucinex®D

600 mg guaifenesin & 60 mg pseudoephedrine HCl
extended-release bi-layer tablets

EXPECTORANT & NASAL DECONGESTANT

12 HOUR

NEW LOOK-
SAME RELIEF

Thins And Loosens Mucus

Clears Nasal/Sinus Congestion

18 EXTENDED-RELEASE BI-LAYER TABLETS

Mucinex D 
guaifenesin and pseudoephedrine hydrochloride tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-057
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Guaifenesin (Guaifenesin) Guaifenesin 600 mg
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 60 mg
Product Characteristics
Color ORANGE, WHITE Score no score
Shape OVAL Size 16mm
Flavor Imprint Code Mucinex;600
Contains     
Packaging
# Item Code Package Description
1 NDC:63824-057-18 2 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 9 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
2 NDC:63824-057-36 4 BLISTER PACK (BLISTER PACK) in 1 CARTON
2 9 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021585 04/17/2009
Labeler - Reckitt Benckiser, Inc. (094405024)
Revised: 12/2009   Reckitt Benckiser, Inc.

How should I take Mucinex D?

Use Mucinex D tablets exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Do not crush, chew or break an extended-release Mucinex D tablet. Swallow the tablet whole. It is specially made to release medicine slowly in the body. Breaking or opening the tablet would cause too much of the drug to be released at one time.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking Mucinex D. Take Mucinex D with food if it upsets your stomach. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Since Mucinex D is usually taken only as needed, you may not be on a dosing schedule. If you are taking Mucinex D regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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