EXCAUGH- guaifenesin tablet 
FORTUNE PHARMACAL COMPANY, LIMITED

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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 ingredientsaspartame, 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 DrugM01204/26/2016
Labeler - FORTUNE PHARMACAL COMPANY, LIMITED (686280561)
Registrant - FORTUNE PHARMACAL COMPANY, LIMITED (686280561)
Establishment
NameAddressID/FEIBusiness Operations
FORTUNE PHARMACAL COMPANY, LIMITED686280561manufacture(51467-009)

Revised: 11/2025
Document Id: 438103e3-da3d-16c8-e063-6394a90ad7f3
Set id: 60803d28-ea6e-4ab9-9cc9-4909b4681ecd
Version: 5
Effective Time: 20251113
 
FORTUNE PHARMACAL COMPANY, LIMITED