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Guaifenesin Extended-Release Package Insert

Status:
Prescription (Rx) Facts
Strength:
600 mg
Drug class:
Active ingredient:
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Prescribing information (package insert) - Guaifenesin Extended-Release

ACTIVE INGREDIENT(in each extended-release tablet)

Guaifenesin 600 mg

PURPOSE

Expectorant

USE(S)

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNING

.

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 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).

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 or 2 tablets every 12 hours.
  • Do not exceed 4 tablets in 24 hours.
  • children under 12 years of age: do not use

OTHER INFORMATION

  • tamper evident: do not use if seal on the bottle printed "SEALED for YOU PROTECTION" is broken or missing.
  • store between 20 to 25°C (68 to 77°F)

INACTIVE INGREDIENTS

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

QUESTIONS?

1-800-616-2471

You may also report side effects to this phone number.

HOW SUPPLIED

Guaifenesin 600 mg: color white, shape capsule and the imprint code is G233.

NDC: 71335-2642-1: 30 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-2: 20 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-3: 60 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-4: 40 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-5: 14 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-6: 6 EXTENDED RELEASE TABLETs in a BOTTLE

Store between 20 to 25°C (68 to 77°F)

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 209215 · View the label on DailyMed

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Drug information for Guaifenesin Extended-Release

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Expectorant
Active ingredient Guaifenesin 600 mg
Dosage form Tablet, extended release
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) GUARDIAN DRUG
FDA approval ANDA 209215Abbreviated New Drug Application (ANDA) – generic drug Approved September 6, 2017
Packages (NDC)
Package
600 mg – 30 in 1 bottle NDC 71335-2642-1
600 mg – 20 in 1 bottle NDC 71335-2642-2
600 mg – 60 in 1 bottle NDC 71335-2642-3
600 mg – 40 in 1 bottle NDC 71335-2642-4
600 mg – 14 in 1 bottle NDC 71335-2642-5
600 mg – 6 in 1 bottle NDC 71335-2642-6

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.