280r Timely 49483-280 Dextromethorphan Hbr 20 Mg And Guaifenesin 400 Mg Tablets

280r Timely 49483-280 Dextromethorphan Hbr 20 Mg And Guaifenesin 400 Mg Tablets
SPL v4
SPL
SPL Set ID 62c1f4aa-6571-414c-9a58-31e107b7db97
Route
ORAL
Published
Effective Date 2025-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg) Dextromethorphan (20 mg)
Inactive Ingredients
Silicon Dioxide Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Povidone Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: TCL280 Shape: round Color: white Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-04-17

Description

Active ingredients (in each immediate-release tablet) Dextromethorphan HBr 20 mg Guaifenesin 400 mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

• helps loosen phlegm (mucus)

• helps thin bronchial secretions to make coughs more productive

• temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

Dosage and Administration

Directions

  • adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
  • children under 12 years of age: do not use
Description

Active ingredients (in each immediate-release tablet) Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Section 50567-7

When using this product

  • do not exceed recommended dosage
  • do not use for more than 7 days
Section 50569-3

Ask a doctor before use if you have

  • cough accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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 colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Section 51945-4

Section 53413-1

Questions or comments?

Call 1-877-290-4008

Section 53414-9

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

Section 55105-1

Purpose

Cough suppressant

Expectorant

Section 55106-9

Active ingredients (in each immediate-release tablet)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Section 60561-8

Other information

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • keep in a dry place and do not expose to excessive heat

Structured Label Content

Indications and Usage (34067-9)

Uses

• helps loosen phlegm (mucus)

• helps thin bronchial secretions to make coughs more productive

• temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

Dosage and Administration (34068-7)

Directions

  • adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 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 (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Section 50567-7 (50567-7)

When using this product

  • do not exceed recommended dosage
  • do not use for more than 7 days
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • cough accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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 colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-877-290-4008

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Cough suppressant

Expectorant

Section 55106-9 (55106-9)

Active ingredients (in each immediate-release tablet)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Section 60561-8 (60561-8)

Other information

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • keep in a dry place and do not expose to excessive heat

Advanced Ingredient Data


Raw Label Data

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