Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 7076e42a-17ff-4c42-9963-2dc02c0a5e49
Route
ORAL
Published
Effective Date 2022-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg)
Inactive Ingredients
Silicon Dioxide Fd&c Blue No. 2 Hypromellose, Unspecified Magnesium Stearate Povidone, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: RH;99 Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
ANDA Active Since 2022-04-01

Description

(in each extended-release tablet) Guaifenesin, USP

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

(in each extended-release tablet) Guaifenesin, USP

Uses
  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bronchial mucus and make coughs more productive
Section 42229-5

Keep the carton. It contains important information. See end panel for expiration date.

†OHM and OHM Logo are trademarks of Ohm Laboratories, Inc. All other trademarks are the property of their respective owners.

Distributed by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901



PRODUCT OF INDIA



R0425

CODE No.: PB/DRUGS/1809-0SP

Warnings

Do not use

  • for children under 12 years of age

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)

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 serious illness.

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

Questions

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

Directions
  • do not crush, chew or break extended-release tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children over 12 years of age and over: one or two extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours.
  • children under 12 years of age: do not use.

Other information

  • store between 20-25°C (68-77°F)
  • TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.
Active Ingredient

(in each extended-release tablet)

Guaifenesin, USP

Inactive Ingredients

colloidal silicon dioxide, FD&C blue # 2, aluminum lake, hypromellose, magnesium stearate, povidone.

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).

Principal Display Panel Guaifenesin Er Tablets, 1200 Mg

Package/label Principal Display Panel Guaifenesin Er Tablets, 600 Mg


Structured Label Content

Uses
  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bronchial mucus and make coughs more productive
Section 42229-5 (42229-5)

Keep the carton. It contains important information. See end panel for expiration date.

†OHM and OHM Logo are trademarks of Ohm Laboratories, Inc. All other trademarks are the property of their respective owners.

Distributed by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901



PRODUCT OF INDIA



R0425

CODE No.: PB/DRUGS/1809-0SP

Purpose

Expectorant

Warnings

Do not use

  • for children under 12 years of age

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)

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 serious illness.

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

Questions

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

Directions
  • do not crush, chew or break extended-release tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children over 12 years of age and over: one or two extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours.
  • children under 12 years of age: do not use.

Other information

  • store between 20-25°C (68-77°F)
  • TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.
Active Ingredient (Active ingredient)

(in each extended-release tablet)

Guaifenesin, USP

Inactive Ingredients

colloidal silicon dioxide, FD&C blue # 2, aluminum lake, hypromellose, magnesium stearate, povidone.

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).

Principal Display Panel Guaifenesin Er Tablets, 1200 Mg (Principal Display Panel - Guaifenesin ER Tablets, 1200 mg)

Package/label Principal Display Panel Guaifenesin Er Tablets, 600 Mg (Package/Label Principal Display Panel - Guaifenesin ER Tablets, 600 mg)


Advanced Ingredient Data


Raw Label Data

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