EXCAUGH- guaifenesin tablet 
FORTUNE PHARMACAL COMPANY, 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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Drug Facts

Active ingredients (in each tablet)
Guaifenesin 100 mg

Purpose
Expectorant

Uses
helps loosen phlegm (mucus) and thin bronchial secretions to:
   rid the bronchial passageways of bothersome mucus
   make coughs more productive

Warnings

Ask a doctor before use if the user has
a persistent or chronic cough such as occurs with:
   smoking
   asthma
   chronic bronchitis
   emphysema
a cough that is accompanied by excessive phlegm (mucus)
a high fever

Stop use and ask a doctor if
any of the following occurs (these could be signs of a serious condition):
   cough persists for more than 1 week
   cough tends to recur
   cough is accompanied by a fever, rash, or persistent headache

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
adults and children 12 years of age and over: take 2 to 4 tablets every 4 hours, not to exceed 24 tablets (2,400 mg) in 24 hours
children 6 to under 12 years of age: take 1 to 2 tablets every 4 hours, not to exceed 12 tablets (1,200 mg) in 24 hours
children under 6 years of age: consult a doctor

Other information

Phenylketonurics: Contains Phenylalanine 3.929 mg Per Tablet
keep tightly sealed

store between 20 to 25º C (68 to 77º F)

Inactive ingredients aspartame, colloidal silicon dioxide, corn starch, D&C yellow no.10 aluminum lake, lactose monohydrate, magnesium stearate, povidone K30, sodium starch glycolate.

Questions or comments?(888) 221-3496 M-F 9 am to 5 pm
you may also report serious side effects to this phone number

EXCAUGH
Guaifenesin - Expectorant
NDC 51467-009-02
36 Tablets
IMAGE OF CARTON

EXCAUGH 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51467-009
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize10mm
FlavorImprint Code FORTUNE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51467-009-012 in 1 BOX04/26/2016
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:51467-009-023 in 1 BOX03/21/2018
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/26/2016
Labeler - FORTUNE PHARMACAL COMPANY, LIMITED (686280561)
Establishment
NameAddressID/FEIBusiness Operations
FORTUNE PHARMACAL COMPANY, LIMITED686280561manufacture(51467-009)

Revised: 10/2018
Document Id: 598d6bd5-7cea-4f3e-bd40-2d7cbc2f49d5
Set id: 60803d28-ea6e-4ab9-9cc9-4909b4681ecd
Version: 3
Effective Time: 20181015
 
FORTUNE PHARMACAL COMPANY, LIMITED