MUCINEX- guaifenesin tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)

Available from:

RB Health (US) LLC

INN (International Name):

Guaifenesin

Composition:

Guaifenesin 600 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Expectorant - helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Authorization status:

New Drug Application

Summary of Product characteristics

MUCINEX- GUAIFENESIN TABLET, EXTENDED RELEASE
RB HEALTH (US) LLC
----------
MUCINEX
_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
store at 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: RB Health (US)
Parsippany, NJ 07054-0224
Made in England
PRINCIPAL DISPLAY PANEL - 20 TABLET BLISTER PACK CARTON
NDC 63824-008-32
Mucinex®
600 mg guaifenesin
extended-release bi-layer tablets
EXPECTORANT
12
HOUR
✓ Relieves Chest Congestion
✓ Thins and Loosens Mucus
✓ Immediate and Extended Release
20
EXTENDED-RELEASE
BI-LAYER TABLETS
®
MUCINEX
guaifenesin tablet, extended release
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:63824-008
RO