Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 7942eeae-0528-4416-bd2f-b05acc71c0a9
Route
ORAL
Published
Effective Date 2022-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg) Dextromethorphan (30 mg)
Inactive Ingredients
Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Silicon Dioxide Fd&c Blue No. 1 Ferric Oxide Yellow Hypromellose 2910 (10000 Mpa.s) Hypromellose 2208 (4000 Mpa.s) Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A

Identifiers & Packaging

Marketing Status
ANDA Active Since 2023-08-15

Description

(in each extended-release tablet) Guaifenesin USP, 600 mg Dextromethorphan Hydrobromide USP, 30 mg

Purpose

Expectorant Cough suppressant


Medication Information

Purpose

Expectorant Cough suppressant

Description

(in each extended-release tablet) Guaifenesin USP, 600 mg Dextromethorphan Hydrobromide USP, 30 mg

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

Section 42229-5

Section 53414-9

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

Purposes

Expectorant

Cough suppressant

Warnings

Questions

call 1-888-375-3784 Weekdays (9am - 8pm EST)

You may also report side effects to this phone number.

Directions

  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • children under 12 years of age: do not use

For 600 mg/30 mg:

  • adults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours.

Do Not Use
  • for children under 12 years of age
  • 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.

Other Information
  • store at 20°C to 25°C (68°F to 77°F)

Active Ingredients

(in each extended-release tablet)

Guaifenesin USP, 600 mg

Dextromethorphan Hydrobromide USP, 30 mg

Inactive Ingredients

carbomer homopolymer type B, colloidal silicon dioxide, FD & C Blue #1, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

When Using This Product
  • do not use more than directed

Stop Use and Ask A Doctor If
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

These could be signs of a serious illness.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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 too much phlegm (mucus)
Package Label Principal Display Panel Section


Structured Label Content

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

Section 42229-5 (42229-5)

Section 53414-9 (53414-9)

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

Purposes

Expectorant

Cough suppressant

Warnings

Questions

call 1-888-375-3784 Weekdays (9am - 8pm EST)

You may also report side effects to this phone number.

Directions

  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • children under 12 years of age: do not use

For 600 mg/30 mg:

  • adults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours.

Do Not Use (Do not use)
  • for children under 12 years of age
  • 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.

Other Information (Other information)
  • store at 20°C to 25°C (68°F to 77°F)

Active Ingredients (Active ingredients)

(in each extended-release tablet)

Guaifenesin USP, 600 mg

Dextromethorphan Hydrobromide USP, 30 mg

Inactive Ingredients (Inactive ingredients)

carbomer homopolymer type B, colloidal silicon dioxide, FD & C Blue #1, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

When Using This Product (When using this product)
  • do not use more than directed

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

These could be signs of a serious illness.

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 (1-800-222-1222).

Ask A Doctor Before Use If You Have (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 too much phlegm (mucus)
Package Label Principal Display Panel Section (PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION)


Advanced Ingredient Data


Raw Label Data

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