MUCINEX D MAXIMUM STRENGTH- guaifenesin and pseudoephedrine hydrochloride tablet, extended release

Mucinex D by

Drug Labeling and Warnings

Mucinex D by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each extended-release bi-layer tablet)	Purposes
Guaifenesin 1200 mg	Expectorant
Pseudoephedrine HCl 120 mg	Nasal Decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage
• temporarily relieves sinus congestion and pressure

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough accompanied by too much phlegm (mucus)

When using this product

• do not use more than directed

Stop use and ask a doctor if

• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days, come back or occur with a 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 timing of meals
• adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
• children under 12 years of age: do not use

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer type B; FD&C yellow #6 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: RB Health (US)
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton

MAXIMUM STRENGTH

NDC: 63824-041-24

Mucinex®D
1200 mg guaifenesin & 120 mg pseudoephedrine HCl
extended-release bi-layer tablets

EXPECTORANT
& NASAL DECONGESTANT

12
HOUR®

• ✔ Clears Nasal/Sinus Congestion
• ✔ Thins and Loosens Mucus
• ✔ Immediate and Extended Release

24
EXTENDED-RELEASE
BI-LAYER TABLETS

INGREDIENTS AND APPEARANCE

MUCINEX D   MAXIMUM STRENGTH
guaifenesin and pseudoephedrine hydrochloride tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-041
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	1200 mg
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F)	Pseudoephedrine Hydrochloride	120 mg

Inactive Ingredients
Ingredient Name	Strength
carbomer homopolymer type B (allyl pentaerythritol crosslinked) (UNII: HHT01ZNK31)
FD&C yellow NO. 6 (UNII: H77VEI93A8)
aluminum oxide (UNII: LMI26O6933)
hypromellose, unspecified (UNII: 3NXW29V3WO)
magnesium stearate (UNII: 70097M6I30)
microcrystalline cellulose (UNII: OP1R32D61U)

Product Characteristics
Color	ORANGE, WHITE	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	Mucinex;1200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-041-24	2 in 1 CARTON	06/26/2012
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 63824-041-71	24 in 1 CARTON	06/26/2012	07/10/2017
2		1 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 63824-041-36	3 in 1 CARTON	06/26/2012	09/12/2017
3		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 63824-041-12	1 in 1 CARTON	01/01/2020
4		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021585	06/26/2012

Labeler - RB Health (US) LLC (081049410)