Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID e2e3c628-d241-42b6-8c1e-ef997ffa6e87
Route
ORAL
Published
Effective Date 2023-12-01
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (1200 mg)
Inactive Ingredients
Silicon Dioxide Hypromellose 2208 (15000 Mpa.s) Hypromellose 2910 (10000 Mpa.s) Magnesium Stearate Microcrystalline Cellulose 101 Microcrystalline Cellulose 102 Povidone K90 Povidone K25 Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: L;69 Shape: oval Color: white Size: 21 mm Score: 1
Marketing Status
ANDA Active Since 2022-06-27

Description

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

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

( in each extended-release tablet) 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
Warnings



Do not use

  • for children under 12 years of age
Directions
  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
  • children under 12 years of age: do not use
Active Ingredient

( in each extended-release tablet)



Guaifenesin USP 1200 mg

Other Information
  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients


colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised 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®, Inc.

East Windsor, NJ 08520



Made in India



Code: AP/DRUGS/04/2016

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 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 1200 Mg Blister Carton (21 Tablets)

12                                    NDC 71179-002-21

HR



CONTAC®

CHEST CONGESTION



Guaifenesin

Extended-Release Tablets 1200 mg

Expectorant



Maximum Strength 

  • Relieves Chest Congestion
  • Thins And 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
Purpose

Expectorant

Warnings



Do not use

  • for children under 12 years of age
Directions
  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
  • children under 12 years of age: do not use
Active Ingredient (Active ingredient)

( in each extended-release tablet)



Guaifenesin USP 1200 mg

Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients (Inactive ingredients)


colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised 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®, Inc.

East Windsor, NJ 08520



Made in India



Code: AP/DRUGS/04/2016

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 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 1200 Mg Blister Carton (21 Tablets) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (21 Tablets))

12                                    NDC 71179-002-21

HR



CONTAC®

CHEST CONGESTION



Guaifenesin

Extended-Release Tablets 1200 mg

Expectorant



Maximum Strength 

  • Relieves Chest Congestion
  • Thins And Loosens Mucus

21 EXTENDED-RELEASE TABLETS






Advanced Ingredient Data


Raw Label Data

All Sections (JSON)