GUAIFENESIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Reliable 1 Laboratories LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Expectorant helps lossen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersone mucus and make coughs more productive Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. these could be signs of a serious illness.

Authorization status:

OTC monograph final

Summary of Product characteristics

GUAIFENESIN- GUAIFENESIN TABLET
RELIABLE 1 LABORATORIES 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._
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GUIFENISEN 400 MG
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH CAPLET)_
Guaifenesin 400 mg
_PURPOSE_
Expectorant
_USES_
helps lossen phlegm (mucus) and thin bronchial secretions to rid the
bronchial
passageways of bothersone mucus and make coughs more productive
_WARNINGS_
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 then 7 days, comes back,
or is
accompanied by fever, rash, or persistent headache. These could be
signes of serious
illness.
STOP USE AND ASK A DOCTOR IF cough lasts more than 7 days, comes back,
or is
accompanied by 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 take more than 6 doses in any 24- hour period
this product is not intended for use in children under 12 years of age
adults & children 12 years and over: 1 caplet every 4 hours
children under 12 years: do not use
_OTHER INFORMATION_
store at 15°-30°C (59°-86°F)
_INACTIVE INGREDIENTS_
colloidal silicon dioxide, magnesium stearate, maltodextrin,
microsrystalline cellulose,
providone, stearic acid
_QUESTIONS OR COMMENTS?_
call 516-341-0666, 8:30 am-4:30 pm ET, Monday-Friday
_DRUG FACTS continued on back of label_
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS
BROKEN OR MISSING
Distributed by: RELIABLE-1 LABORATOREIS LLC
VALLEY STREAM, NY 11580 WWW.RELIABLE1LABS.COM
NDC 69618-061-06
RELIABLE-1 LABORATORIES
GUAIFENESIN 400 MG
EXPECTORANT
60 CA