SIMPEX GUAIFENESIN- guaifenesin tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Simpex Pharma Pvt. Ltd

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

SIMPEX GUAIFENESIN - GUAIFENESIN TABLET
SIMPEX PHARMA PVT. LTD
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SIMPEX GUAIFENESIN
DRUG FACTS
_ACTIVE INGREDIENT (IN EACH TABLET)_
Guaifenesin 400 mg
_PURPOSE_
Expectorant
_USES_
helps loosen phlegm (mucus) and thin bronchial secretions to make
coughs
more productive to rid the bronchial passageway of bothersome mucus
_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 with excessive phlegm (mucus)
STOP USE AND ASK A DOCTOR IF
cough lasts more than 7 days, recurs, or is accompanied with fever,
rash, or
persistent headache.These could be signs of a serious condition.
IF PREGNANT OR BREAST-FEEDING,
ask a health care 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_
adults & children 12 years of age and older : take a tablet every 4
hours with a full
glass of water while symptoms persist. Do not exceed 6 doses in 24
hours.
children under 12 years of age : do not use.
_OTHER INFORMATION_
preserve in tight containers at a temperature not exceeding 30°C.
_INACTIVE INGREDIENTS_
colloidal anhydrous silica, magnesium stearate, maltodextrin,
microcrystalline
cellulose, povidone, pregelatinised starch, sodium starch glycolate
type A, stearic acid
PACKAGE LABELING:
SIMPEX GUAIFENESIN
guaifenesin tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:76457-004
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)
GUAIFENESIN
400 mg
Simpex Pharma Pvt. Ltd
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
PRODUCT CHARACTERISTICS
COLOR
red (Iron oxide red, Iron oxide yel