GUAIFENESIN EXTENDED RELEASE EXTENDED RELEASE- 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:

NCS HealthCare of KY, Inc dba Vangard Labs

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:

Abbreviated New Drug Application

Summary of Product characteristics

GUAIFENESIN EXTENDED RELEASE EXTENDED RELEASE- GUAIFENESIN TABLET,
EXTENDED
RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
GUAIFENESIN ER TABS
ACTIVE INGREDIENT (IN EACH EXTENDED-RELEASE TABLET)
Guaifenesin 600 mg
PURPOS E
Expectorant
US ES
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. (1-800-222-1222)
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: one or two tablets every
12 hours. Do not exceed 4
tablets in 24 hours.
children under 12 years of age: do not use
OTHER INFORMATION
do not use if printed seal under cap is broken or missing
store between 20-25°C (68-77°F)
INACTIVE INGREDIENTS
compressible sugar, copovidone, hydroxyethyl cellulose, silicon
dioxide, zinc stearate
QUESTIONS OR COMMENTS?
1-800-719-9260
Distributed by Perrigo
Allegan, MI 49010
www.perrigo.com
49878 RT F3
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
GUAIFENESIN EXTENDED RELEASE EXTENDED RELEASE
guaifenesin tablet, extended release
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:0 6 15-7712(NDC:458 0 2-49 8 )
®
NCS HealthCare of KY, Inc dba Vangard Labs
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
GUAIFENESIN (UNII: 49 5W7451VQ)