GUAIFENESIN liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Method Pharmaceuticals, LLC

INN (International Name):

GUAIFENESIN

Composition:

GUAIFENESIN 100 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Expectorant - helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Authorization status:

OTC monograph final

Summary of Product characteristics

GUAIFENESIN- GUAIFENESIN LIQUID
METHOD PHARMACEUTICALS, LLC
----------
GUAIFENESIN
NDC 58657-509-16
GUAIFENESIN
LIQUID USP
100 mg/5 Ml
Expectorant
Sugar Free • Alcohol Free
Cherry Flavor
Loosens and Relieves Chest Congestion
16 fl. oz. (473 mL)
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH 5 ML)_
Guaifenesin 100 mg
_PURPOSE_
Expectorant
_USES_
helps loosen phlegm (mucus) and thin bronchial secretions to make
coughs more
productive.
_WARNINGS_
ASK A DOCTOR BEFORE USE IF YOU HAVE
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma,
chronic
bronchitis, or emphysema
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 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 right away.
_DIRECTIONS_
do not take more than 6 doses in any 24-hour period
age dose adults and children 2 to 4 teaspoonfuls
12 years and over every 4 hours
children 6 years to 1 to 2 teaspoonfuls
under 12 years every 4 hours
children 2 years to ½ to 1 teaspoonful
under 6 years every 4 hours
children under 2 years ask a doctor
_DRUG FACTS _(continued)
_OTHER INFORMATION_
store at 20°-25°C (68°-77°F)
packaged with tamper evident seal under cap
_INACTIVE INGREDIENTS_
Bitter Mask, Cherry Flavor, Citric Acid, FD&C Red#40, Glycerin,
Propylene Glycol, Purified
Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol
Solution
_QUESTIONS OR COMMENTS_
1-877-250-3427
Manufactured For:
METHOD PHARMACEUTICALS, LLC
Fort Worth, Texas 76118 Rev. 09/16
PRINCIPAL DISPLAY PANEL
NDC 58657- 509- 16
Guaifenesin
Liquid USP
100 mg/ 5 mL
Expectorant
16 fl. oz. (473 mL)
GUAIFENESIN
guaifenesin liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:58657-509
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF S