CURNEX- guaifenesin 400mg tablet

CurNEX by

Drug Labeling and Warnings

CurNEX by is a Otc medication manufactured, distributed, or labeled by Wittman Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions

• take with full glass of water
• do not exceed 6 doses in 24 hours

• Adults and children 12 years of age and over; take 1 tablet every 4 hours while symptoms persist
• Children under 12 years of age; do not use

WARNINGS

Warnings

Ask a doctor before use if you have * persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema * cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if * cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious illness.

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.

INACTIVE INGREDIENT

Inactive Ingredients: Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

INDICATIONS & USAGE

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

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.

PURPOSE

Purpose: Expectorant

ACTIVE INGREDIENT

Guaifenesin 400 mg

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CURNEX 
guaifenesin 400mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83335-003
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	13mm
Flavor		Imprint Code	GN
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83335-003-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/01/2024

Labeler - Wittman Pharma, Inc. (830980947)

Establishment
Name	Address	ID/FEI	Business Operations
Wittman Pharma, Inc.		830980947	analysis(83335-003) , manufacture(83335-003) , label(83335-003)