GUAAP - guaifenesin liquid 
A P J Laboratories Limited

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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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 Type HUMAN OTC DRUG Item Code (Source) NDC:46084-051
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
MENTHOL (UNII: L7T10EIP3A) 10 ug  in 5 mL
SUCROSE (UNII: C151H8M554) 200 mg  in 5 mL
SORBITOL (UNII: 506T60A25R) 50 mg  in 5 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 1 mg  in 5 mL
BRONOPOL (UNII: 6PU1E16C9W) 0.5 mg  in 5 mL
EDETIC ACID (UNII: 9G34HU7RV0) 0.5 mg  in 5 mL
ASPARTAME (UNII: Z0H242BBR1) 1 mg  in 5 mL
XANTHAN GUM (UNII: TTV12P4NEE) 0.5 mg  in 5 mL
Product Characteristics
Color yellow Score     
Shape Size
Flavor RASPBERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:46084-051-21 120 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/01/2013
Labeler - A P J Laboratories Limited (677378339)
Registrant - A P J Laboratories Limited (677378339)
Establishment
Name Address ID/FEI Business Operations
A P J Laboratories Limited 677378339 manufacture(46084-051)

Revised: 2/2013
Document Id: b4133ea4-5e75-46d7-80b4-e7350c8ce234
Set id: 6f6f3aae-a676-4b91-bad3-2a1c798ffe0a
Version: 1
Effective Time: 20130228
 
A P J Laboratories Limited