EXCAUGH- guaifenesin tablet

EXCAUGH by

Drug Labeling and Warnings

EXCAUGH by is a Otc medication manufactured, distributed, or labeled by FORTUNE PHARMACAL COMPANY, LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each tablet)
Guaifenesin 100 mg

PURPOSE

Purpose
Expectorant

INDICATIONS & USAGE

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

WARNINGS

Warnings

ASK DOCTOR

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

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

Phenylketonurics: Contains Phenylalanine 3.929 mg Per Tablet
keep tightly sealed

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

INACTIVE INGREDIENT

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

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

PRINCIPAL DISPLAY PANEL

EXCAUGH
Guaifenesin - Expectorant
NDC: 51467-009-02
36 Tablets

INGREDIENTS AND APPEARANCE

EXCAUGH 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51467-009
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	FORTUNE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51467-009-01	2 in 1 BOX	04/26/2016
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 51467-009-02	3 in 1 BOX	03/21/2018
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/26/2016

Labeler - FORTUNE PHARMACAL COMPANY, LIMITED (686280561)

Establishment
Name	Address	ID/FEI	Business Operations
FORTUNE PHARMACAL COMPANY, LIMITED		686280561	manufacture(51467-009)