NASAL AND CHEST DECONGESTANT- guaifenesin, pseudoephedrine hydrochloride tablet, multilayer, extended release

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredients (in each extended-release tablet)

Guaifenesin 1200 mg

Pseudoephedrine HCl 120 mg

Purposes

Expectorant

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 (1-800-222-1222).

Directions

• do not crush, chew, or break extended-release 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 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours
• children under 12 years of age: do not use

Other information

• store at 68-77°F (20-25°C)

Inactive ingredients

carbomer homopolymer type B, colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Package/Label Principal Display Panel

Maximum Strength

Nasal & Chest Decongestant

Extended Release

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 1200 mg/120 mg EXPECTORANT/NASAL DECONGESTANT

Clears nasal & sinus congestion

Thins & loosens mucus

Immediate & extended release

Relieves nasal & chest congestion

12 hour

ACTUAL SIZE

24 Extended-release tablets

Compare to Maximum Strength Mucinex® D active ingredients.

INGREDIENTS AND APPEARANCE

NASAL AND CHEST DECONGESTANT 
guaifenesin, pseudoephedrine hydrochloride tablet, multilayer, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56062-614
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	L12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56062-614-62	4 in 1 CARTON	04/02/2026
1		6 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
ANDA	ANDA214407	04/02/2026

Labeler - Publix Super Markets Inc (006922009)