Your browser does not support JavaScript! GUAAP (GUAIFENESIN) LIQUID [A P J LABORATORIES LIMITED]
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RxNorm Names

GUAAP (guaifenesin) liquid
[A P J Laboratories Limited]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

purpose


Expectorant

keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

uses

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

warning

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 for more than 7 days, comes back, or occurs with fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.







direction

•do not take more than 6 doses in any 24-hour period

•this adult product is not intended for use in children under 12 years of age
age dose

adults and children 12 years and over: 2-4 teaspoons every 4 hours


children under 12 years: do not use

inactive ingredient

ASPARTAME

BRONOPOL

EDETIC ACID

MENTHOL


SUCROSE

SODIUM BENZOATE

SORBITOL

XANTHAN GUM

GUAIFENESIN

product
GUAAP 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:46084-051
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
MENTHOL10 ug  in 5 mL
SUCROSE200 mg  in 5 mL
SORBITOL50 mg  in 5 mL
SODIUM BENZOATE1 mg  in 5 mL
BRONOPOL0.5 mg  in 5 mL
EDETIC ACID 0.5 mg  in 5 mL
ASPARTAME1 mg  in 5 mL
XANTHAN GUM0.5 mg  in 5 mL
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46084-051-21120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2013
Labeler - A P J Laboratories Limited (677378339)
Registrant - A P J Laboratories Limited (677378339)
Establishment
NameAddressID/FEIBusiness Operations
A P J Laboratories Limited677378339manufacture(46084-051)

Revised: 2/2013
 
A P J Laboratories Limited

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