Guaifenesin by APNAR PHARMA LP / INVAHEALTH INC / Apnar Pharma Private Limited GUAIFENESIN tablet

Guaifenesin by

Drug Labeling and Warnings

Guaifenesin by is a Otc medication manufactured, distributed, or labeled by APNAR PHARMA LP, INVAHEALTH INC, Apnar Pharma Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BOXED WARNING

(What is this?)

Caution: do not use if imprinted seal under cap is broken or missing.

ACTIVE INGREDIENT

Drug Facts
Active Ingredient (per tablet)
Guaifenesin USP............. 400 mg

PURPOSE

Purpose
Expectorant

INDICATIONS & USAGE

Use

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

WARNINGS

Warnings

Ask doctor before use if you have

• persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema
• cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

• Symptoms are accompanied by fever, rash or persistent headache
• cough persists for more than 1 week or tends to recur
• A persistent cough may be a sign of a serious condition

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 immediately.

DOSAGE & ADMINISTRATION

Directions

• Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
• Children 6 to 12 years of age: take 1/2 tablet every 4 hours as needed
• Children under 6 years of age: consult a doctor

Do not exceed 6 doses in a 24 hour period or as directed by a doctor

STORAGE AND HANDLING

Other Information

• store at 15°-30°C (59°-86°F)

INACTIVE INGREDIENT

Inactive ingredients

Microcrystalline cellulose, Croscarmellose sodium, Povidone, Silicon dioxide, magnesium stearate

QUESTIONS

Questions or concerns?

• 1-855-642-2594

SPL UNCLASSIFIED SECTION

Distributed by:

APNAR PHARMA LP

CHINO, CA, 91710

Rev.: 04/2022

PRINCIPAL DISPLAY PANEL

APNAR PHARMA LP

NDC : 24689-122-01

Guaifenesin Tablets 400mg-20's Tablets

APNAR PHARMA LP

NDC : 24689-122-02

Guaifenesin Tablets 400mg-500's Tablets

INGREDIENTS AND APPEARANCE

GUAIFENESIN 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24689-122
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (White to off White color)	Score	2 pieces
Shape	ROUND	Size	13mm
Flavor		Imprint Code	LT;12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24689-122-01	20 in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2022
2	NDC: 24689-122-02	500 in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/30/2022

Labeler - APNAR PHARMA LP (079568229)

Establishment
Name	Address	ID/FEI	Business Operations
INVAHEALTH INC		116840615	label(24689-122) , pack(24689-122)

Establishment
Name	Address	ID/FEI	Business Operations
Apnar Pharma Private Limited		876730408	analysis(24689-122) , manufacture(24689-122)