Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 1c8fbf40-17c1-4ee9-a2b9-ca4a08e08293
Route
ORAL
Published
Effective Date 2025-04-04
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (1200 mg) Dextromethorphan (60 mg)
Inactive Ingredients
Silicon Dioxide Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Povidone K90 Povidone K25 Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: X;63 Shape: oval Color: white Size: 22 mm Score: 1
Marketing Status
ANDA Active Since 2022-07-14
Description

( in each extended-release tablet) Dextromethorphan Hydrobromide USP 60 mg Guaifenesin USP 1200 mg

Purpose

Cough suppressant Expectorant

Medication Information

Purpose

Cough suppressant

Expectorant

Description

( in each extended-release tablet) Dextromethorphan Hydrobromide USP 60 mg Guaifenesin USP 1200 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
Warnings



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.
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
  • adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
  • children under 12 years of age: do not use
Other Information


  • store at 20° to 25°C (68° to 77°F)
Active Ingredients

( in each extended-release tablet)

Dextromethorphan Hydrobromide USP 60 mg

Guaifenesin USP 1200 mg

Inactive Ingredients


colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)

Questions Or Comments?

Call toll-free, 1-855-874-0970 (English/Spanish) weekdays You may also report side effects to this phone number.



DISTRIBUTED BY:

Vespyr Brands®, LLC.

East Windsor NJ 08520



Made in India



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.
If Pregnant Or Breast Feeding,


ask a health professional before use.

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.

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 1200 Mg/60 Mg Blister Carton (21 (3 X 7)tablets)

12                                    NDC 71179-011-21

HOUR

CONTAC®

COUGH & CONGESTION

Dextromethorphan HBr 60mg

& Guaifenesin 1200mg

Cough Suppressant & Expectorant

MAXIMUM STRENGTH 



• Controls Cough

• Relieves Chest Congestion • Thins & Loosens Mucus

21 EXTENDED-RELEASE TABLETS



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
Purpose

Cough suppressant

Expectorant

Warnings



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.
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
  • adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
  • children under 12 years of age: do not use
Other Information (Other information)


  • store at 20° to 25°C (68° to 77°F)
Active Ingredients (Active ingredients)

( in each extended-release tablet)

Dextromethorphan Hydrobromide USP 60 mg

Guaifenesin USP 1200 mg

Inactive Ingredients (Inactive ingredients)


colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)

Questions Or Comments? (Questions or comments?)

Call toll-free, 1-855-874-0970 (English/Spanish) weekdays You may also report side effects to this phone number.



DISTRIBUTED BY:

Vespyr Brands®, LLC.

East Windsor NJ 08520



Made in India



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.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)


ask a health professional before use.

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 (1-800-222-1222) right away.

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 1200 Mg/60 Mg Blister Carton (21 (3 X 7)tablets) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg Blister Carton (21 (3 x 7)Tablets))

12                                    NDC 71179-011-21

HOUR

CONTAC®

COUGH & CONGESTION

Dextromethorphan HBr 60mg

& Guaifenesin 1200mg

Cough Suppressant & Expectorant

MAXIMUM STRENGTH 



• Controls Cough

• Relieves Chest Congestion • Thins & Loosens Mucus

21 EXTENDED-RELEASE TABLETS



Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:52.065075 · Updated: 2026-03-14T23:08:14.770901