Guaifenesin Extended Release Tablets 600 Mg

SPL v4

SPL

SPL Set ID ee8a2a97-16aa-0f3e-e053-2a95a90a523b

Route

ORAL

Published

Effective Date 2022-11-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (600 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;68 Shape: oval Color: white Size: 16 mm Score: 1

Marketing Status

ANDA Active Since 2023-03-15

Description

(in each extended-release tablet) Guaifenesin USP 600 mg

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

(in each extended-release tablet) Guaifenesin USP 600 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 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
children under 12 years of age: do not use

Questions?

1-855-274-4122(Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number.

Manufactured by:

APL Healthcare Limited Unit-IV.

Tirupati (Dt) - 524421, India

For BluePoint Laboratories

Made in India

Code: AP/DRUGS/04/2016

Rev: 10/2022

Active Ingredient

(in each extended-release tablet)

Guaifenesin USP 600 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)

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.

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).

If Pregnant Or Breast Feeding,

ask a health professional before use.

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 600 Mg Blister Foil and 600 Mg Carton (80 Extended Release Tablets, 1x10's).

Blister Pack : NDC 68001-561-16

Carton Pack : NDC 68001-561-17

Guaifenesin Extended-Release Tablets 600 mg

EXPECTORANT

12 HOUR

Relieves Chest Congestion
Thins And Loosens Mucus

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

Questions?

1-855-274-4122(Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number.

Manufactured by:

APL Healthcare Limited Unit-IV.

Tirupati (Dt) - 524421, India

For BluePoint Laboratories

Made in India

Code: AP/DRUGS/04/2016

Rev: 10/2022

Active Ingredient (Active ingredient)

(in each extended-release tablet)

Guaifenesin USP 600 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)

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.

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).

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

ask a health professional before use.

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 600 Mg Blister Foil and 600 Mg Carton (80 Extended Release Tablets, 1x10's). (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg Blister Foil and 600 mg Carton (80 Extended-Release Tablets, 1x10's).)

Blister Pack : NDC 68001-561-16

Carton Pack : NDC 68001-561-17

Guaifenesin Extended-Release Tablets 600 mg

EXPECTORANT

12 HOUR

Relieves Chest Congestion
Thins And Loosens Mucus

80 Extended-Release Tablets

Advanced Ingredient Data

[{"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2208 (15000 MPA.S)", "unii": "Z78RG6M2N2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (10000 MPA.S)", "unii": "0HO1H52958", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE 101", "unii": "7T9FYH5QMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE 102", "unii": "PNR0YF693Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K90", "unii": "RDH86HJV5Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K25", "unii": "K0KQV10C35", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "600", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. children under 12 years of age: do not use", "Questions?": "1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number. Manufactured by: APL Healthcare Limited Unit-IV. Tirupati (Dt) - 524421, India For BluePoint Laboratories Made in India Code: AP/DRUGS/04/2016 Rev: 10/2022", "Active ingredient": "(in each extended-release tablet) Guaifenesin USP 600 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)", "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.", "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).", "If pregnant or breast-feeding,": "ask a health professional before use.", "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 - 600 mg Blister Foil and 600 mg Carton (80 Extended-Release Tablets, 1x10's).": "Blister Pack : NDC 68001-561-16 Carton Pack : NDC 68001-561-17 Guaifenesin Extended-Release Tablets 600 mg EXPECTORANT 12 HOUR Relieves Chest Congestion Thins And Loosens Mucus 80 Extended-Release Tablets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:29.552968 · Updated: 2026-03-14T23:02:05.629064