Dextromethorphan Hydrobromide 10 Mg And Guaifenesin 200 Mg Softgelatin Capsules

Dextromethorphan Hydrobromide 10 Mg And Guaifenesin 200 Mg Softgelatin Capsules
SPL v2
SPL
SPL Set ID 2fbbfc7c-81a9-b647-e063-6394a90a55ac
Route
ORAL
Published
Effective Date 2026-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Glycerin Fd&c Blue No. 1 Sorbitol Water Polyethylene Glycol 400 D&c Yellow No. 10 Titanium Dioxide Gelatin Povidone K30

Identifiers & Packaging

Pill Appearance
Shape: oval Color: green Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-21

Description

Dextromethorphan HBr USP 10mg Guaifenesin USP 200mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get to sleep
Dosage and Administration

Directions

  • do not take more than 12 liquid gels in any 24-hour period
  • adults and children 12 years of age and over: take 2 liquid gels every 4 hours
  • children under 12 years of age: do not use
Description

Dextromethorphan HBr USP 10mg Guaifenesin USP 200mg

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a poison control center right away.

Section 50566-9

Stop use and ask a doctor if

  • cough lasts more than 7 days,comes back,or occur with fever, rash, or headache that lasts.

These could be signs of a serious condition.

Section 50567-7

When using this product do not use more than directed

Section 50569-3

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm(mucus)
Section 50570-1

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 taking this product.
Section 51727-6

Inactive ingredients

D&C yellow 10, FD&C blue 1, gelatin, glycerin, polyethylene glycol 400, povidone k-30, purified water, sorbitol sorbitan solution, titanium dioxide

Section 51945-4

Section 53414-9

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

Section 55105-1

Purposes

Cough suppresent

Expectorant

Section 60561-8

Other information

  • store at 20-25°C (68-77°F)
  • avoid excessive heat
Active Ingredient (in Each Soft Gelatin Capsule)

Dextromethorphan HBr USP 10mg

Guaifenesin USP 200mg


Structured Label Content

Indications and Usage (34067-9)

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get to sleep
Dosage and Administration (34068-7)

Directions

  • do not take more than 12 liquid gels in any 24-hour period
  • adults and children 12 years of age and over: take 2 liquid gels every 4 hours
  • children under 12 years of age: do not use
Warnings and Precautions (34071-1)

Warnings

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact a poison control center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • cough lasts more than 7 days,comes back,or occur with fever, rash, or headache that lasts.

These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product do not use more than directed

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm(mucus)
Section 50570-1 (50570-1)

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 taking this product.
Section 51727-6 (51727-6)

Inactive ingredients

D&C yellow 10, FD&C blue 1, gelatin, glycerin, polyethylene glycol 400, povidone k-30, purified water, sorbitol sorbitan solution, titanium dioxide

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Cough suppresent

Expectorant

Section 60561-8 (60561-8)

Other information

  • store at 20-25°C (68-77°F)
  • avoid excessive heat
Active Ingredient (in Each Soft Gelatin Capsule) (Active ingredient (in each soft gelatin capsule))

Dextromethorphan HBr USP 10mg

Guaifenesin USP 200mg


Advanced Ingredient Data


Raw Label Data

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