GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE tablet

Guaifenesin and Dextromethorphan Hydrobromide by

Drug Labeling and Warnings

Guaifenesin and Dextromethorphan Hydrobromide by is a Otc medication manufactured, distributed, or labeled by APNAR PHARMA LP, Apnar Pharma Private Limited, APNAR PHARMA LLP. 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 Ingredients (per tablet)

Guaifenesin USP...................................... 400 mg

Dextromethorphan Hydrobromide USP...... 20 mg

PURPOSE

Purpose

Expectorant

Cough suppressant

INDICATIONS & USAGE

Uses:

• Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold
• Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
• Helps make coughs more productive.

WARNINGS

WARNINGS

Do not use

• if you are now taking a prescription Monoamine Oxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before using this product.

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 phegm (mucus)

Stop use and ask a doctor if

• Symptons 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 healthcare professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

In case of overdose, get medical help or contact 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 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: 24689-123-01

Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 + 20mg- 20s tablets

APNAR PHARMA LP

NDC: 24689-123-02

Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 + 20mg- 500s tablets

INGREDIENTS AND APPEARANCE

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
guaifenesin and dextromethorphan hydrobromide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24689-123
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg

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

Product Characteristics
Color	white	Score	2 pieces
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	LT13
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24689-123-01	20 in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2022
2	NDC: 24689-123-02	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/30/2022

Labeler - APNAR PHARMA LP (079568229)

Establishment
Name	Address	ID/FEI	Business Operations
Apnar Pharma Private Limited		876730408	analysis(24689-123) , manufacture(24689-123)

Establishment
Name	Address	ID/FEI	Business Operations
APNAR PHARMA LLP		118530917	pack(24689-123) , label(24689-123)