Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 +20 mg

BOXED WARNING SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients (per tablet)

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

Dextromethorphan Hydrobromide USP...... 20 mg

OTC - PURPOSE SECTION

Purpose

Expectorant

Cough suppressant

INDICATIONS & USAGE SECTION

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 SECTION

WARNINGS

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

In case of overdose, get medical help or contact poison control center immediately

DOSAGE & ADMINISTRATION SECTION

Directions

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

• 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.

STORAGE AND HANDLING SECTION

Other Information

• store at 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

Inactive Ingredients

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

OTC - QUESTIONS SECTION

Questions or concerns?

• 1-855-642-2594

SPL UNCLASSIFIED SECTION

Distributed by:

APNAR PHARMA LP

CHINO, CA, 91710

Rev.: 04/2022

PACKAGE LABEL.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