FOSTER AND THRIVE CHEST CONGESTION RELIEF- guaifenesin tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)

Available from:

Strategic Sourcing Services LLC

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  - helps make coughs more productive Stop use and ask doctor if - Symptoms are accompanied by fever, rash or persistent headache - cough persists for more than 1 week or tends to recur

Authorization status:

OTC monograph final

Summary of Product characteristics

FOSTER AND THRIVE CHEST CONGESTION RELIEF- GUAIFENESIN TABLET
STRATEGIC SOURCING SERVICES LLC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
----------
DRUG FACTS
ACTIVE INGREDIENT (per tablet)
Guaifenesin 400mg
PURPOSE
Expectorant
USES
helps loosen phlegm (mucus) and thin bronchial secretions to rid the
bronchial
passageways of bothersome mucus
helps make coughs more productive
WARNINGS
ASK DOCTOR BEFORE USE IF YOU HAVE
persistent or chronic cough, such as occurs with smoking, asthma,
bronchitis or
emphysema
cough is accompanied by excessive phlegm (mucus)
STOP USE AND ASK DOCTOR IF
Symptoms are accompanied by fever, rash or persistent headache
cough persists for more than 1 week or tends to recur
A PERSISTENT COUGH MAY BE A SIGN OF A SERIOUS CONDITION.
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 immediately.
DIRECTIONS
ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER: take 1 tablet every 4
hours as
needed
CHILDREN 6 TO 10 UNDER 12 YEARS OF AGE: take 1/2 tablet every 4 hours
as needed
CHILDREN UNDER 6 YEARS OF AGE: consult a doctor
DO NOT EXCEED 6 DOSES IN A 24 HOUR PERIOD OR AS DIRECTED BY A DOCTOR
OTHER INFORMATION
store at 15°-30°C (59°-86°F)
INACTIVE INGREDIENTS
magnesium stearate, microcrystalline cellulose. May also contain
(colloidal) silicon
dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium
starch glycolate,
stearic acid.
FOSTER AND THRIVE CHEST CONGESTION RELIEF
guaifenesin tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:70677-1054
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
GUAIFENESIN (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)
Guaifenes in
400 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
MALTODEXTRI