Guaifenesin And Pseudoephedrine Hcl Extended-release Tablets, 600 Mg/60 Mg And 1200 Mg/120 Mg

SPL v4

SPL

SPL Set ID 75f4ff44-02e7-4a23-a394-85fe8b442e1a

Route

ORAL

Published

Effective Date 2024-10-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (600 mg) Pseudoephedrine (60 mg)

Inactive Ingredients

Magnesium Stearate Fd&c Yellow No. 6 Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Cellulose, Microcrystalline Sodium Starch Glycolate Type A Hypromellose 2910 (5 Mpa.s) Hypromellose 2910 (10000 Mpa.s)

Identifiers & Packaging

Pill Appearance

Imprint: GP;1200 Shape: oval Color: orange Size: 16 mm Size: 22 mm Score: 1

Marketing Status

ANDA Active Since 2023-06-01

Description

(For 600 mg/60 mg) Guaifenesin USP, 600 mg Pseudoephedrine HCL USP, 60 mg (For 1200 mg/120 mg) Guaifenesin USP, 1200 mg Pseudoephedrine HCL USP, 120 mg

Purpose

Expectorant Nasal Decongestant

Medication Information

Purpose

Expectorant Nasal Decongestant

Description

(For 600 mg/60 mg) Guaifenesin USP, 600 mg Pseudoephedrine HCL USP, 60 mg (For 1200 mg/120 mg) Guaifenesin USP, 1200 mg Pseudoephedrine HCL USP, 120 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 nasal congestion due to:

• common cold

• hay fever

• upper respiratory allergies

• temporarily restores freer breathing through the nose

• promotes nasal and/or sinus drainage

• temporarily relieves sinus congestion and pressure

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Centre right away (1-800 222-1222).

Section 53414-9

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

Purposes

Expectorant

Nasal Decongestant

Warnings

 Do not use 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 extended-release 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:

For 600 mg/60 mg: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours

For 1200 mg/120 mg: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours

• children under 12 years of age: do not use

Other Information

• Tamper evident: do not use if carton is open or if printed seal on blister is broken or missing.

• store between 20-25°C (68-77°F)

Inactive Ingredients

carbomer homopolymer Type B, cellulose microcrystalline, hypromellose, lake of FD&C yellow 6, magnesium stearate, sodium starch glycolate Type A

Questions Or Comments?

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

You may also report side effects to this phone number.

Keep the carton.

It contains important information. See end panel for expiration date.

Manufactured By:

Granules India Limited

Hyderabad – 500 081, INDIA

MADE IN INDIA

Distributed By:

Granules USA, Inc.

Parsippany, NJ 07054

When Using This Product

• do not use more than directed

Stop Use and Ask A Doctor If

• you get nervous, dizzy, or sleepless

• symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

Ask A Doctor Before Use If You Have

• heart disease

• high blood pressure

• thyroid disease

• diabetes

• trouble urinating due to an enlarged prostate gland

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

• cough accompanied by too much phlegm (mucus)

Active Ingredients (in Each Extended Release Tablet)

(For 600 mg/60 mg)

Guaifenesin USP, 600 mg

Pseudoephedrine HCL USP, 60 mg

(For 1200 mg/120 mg)

Guaifenesin USP, 1200 mg

Pseudoephedrine HCL USP, 120 mg

Principal Display Panel 600 Mg and 60 Mg Blister Foil Label

Principal Display Panel 1200 Mg and 120 Mg Blister Foil Label

Principal Display Panel 600 Mg and 60 Mg Blister Carton Label

NDC 62207-827-72 ^†Compare To

the active ingredients of

Mucinex ^® D

Guaifenesin and

Pseudoephedrine Hydrochloride FOR DAY OR NIGHT

Extended-Release Tablets 12HR

600 mg and 60 mg

Guaifenesin 600 mg - Expectorant • Clears Nasal & Sinus Congestion

Pseudoephedrine HCl 60 mg - Nasal Decongestant • Thins & Loosens Mucus

• Immediate & Extended Release

RELIEVES NASAL & CHEST CONGESTION

90 (9x10) Extended-Release Tablets

Principal Display Panel 1200 Mg and 120 Mg Blister Carton Label

NDC 62207-828-71 ^†Compare To

the active ingredients of

Mucinex ^® D

Guaifenesin and

Pseudoephedrine Hydrochloride FOR DAY OR NIGHT

Extended-Release Tablets 12HR

1200 mg and 120 mg

Guaifenesin 1200 mg - Expectorant • Clears Nasal & Sinus Congestion

Pseudoephedrine HCl 120 mg - Nasal Decongestant • Thins & Loosens Mucus

• Immediate & Extended Release

RELIEVES NASAL & CHEST CONGESTION

70 (7x10) Extended-Release Tablets

Structured Label Content

Uses

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Centre right away (1-800 222-1222).

Section 53414-9 (53414-9)

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

Purposes

Expectorant

Nasal Decongestant

Warnings

Directions

Other Information (Other information)

• Tamper evident: do not use if carton is open or if printed seal on blister is broken or missing.

• store between 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

carbomer homopolymer Type B, cellulose microcrystalline, hypromellose, lake of FD&C yellow 6, magnesium stearate, sodium starch glycolate Type A

Questions Or Comments? (Questions or comments?)

Distributed By:

Granules USA, Inc.

Parsippany, NJ 07054

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)

• you get nervous, dizzy, or sleepless

• symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

Active Ingredients (in Each Extended Release Tablet) (Active ingredients (in each extended-release tablet))

(For 600 mg/60 mg)

Guaifenesin USP, 600 mg

Pseudoephedrine HCL USP, 60 mg

(For 1200 mg/120 mg)

Guaifenesin USP, 1200 mg

Pseudoephedrine HCL USP, 120 mg

Principal Display Panel 600 Mg and 60 Mg Blister Foil Label (PRINCIPAL DISPLAY PANEL 600 mg and 60 mg - Blister Foil Label)

Principal Display Panel 1200 Mg and 120 Mg Blister Foil Label (PRINCIPAL DISPLAY PANEL 1200 mg and 120 mg - Blister Foil Label)

Principal Display Panel 600 Mg and 60 Mg Blister Carton Label (PRINCIPAL DISPLAY PANEL 600 mg and 60 mg - Blister Carton Label)

NDC 62207-827-72 ^†Compare To

the active ingredients of

Mucinex ^® D

Guaifenesin and

Pseudoephedrine Hydrochloride FOR DAY OR NIGHT

Extended-Release Tablets 12HR

600 mg and 60 mg

Guaifenesin 600 mg - Expectorant • Clears Nasal & Sinus Congestion

Pseudoephedrine HCl 60 mg - Nasal Decongestant • Thins & Loosens Mucus

• Immediate & Extended Release

RELIEVES NASAL & CHEST CONGESTION

90 (9x10) Extended-Release Tablets

Principal Display Panel 1200 Mg and 120 Mg Blister Carton Label (PRINCIPAL DISPLAY PANEL 1200 mg and 120 mg - Blister Carton Label)

NDC 62207-828-71 ^†Compare To

the active ingredients of

Mucinex ^® D

Guaifenesin and

Pseudoephedrine Hydrochloride FOR DAY OR NIGHT

Extended-Release Tablets 12HR

1200 mg and 120 mg

Guaifenesin 1200 mg - Expectorant • Clears Nasal & Sinus Congestion

Pseudoephedrine HCl 120 mg - Nasal Decongestant • Thins & Loosens Mucus

• Immediate & Extended Release

RELIEVES NASAL & CHEST CONGESTION

70 (7x10) Extended-Release Tablets

Advanced Ingredient Data

[{"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "HHT01ZNK31", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (5 MPA.S)", "unii": "R75537T0T4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (10000 MPA.S)", "unii": "0HO1H52958", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "600", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PSEUDOEPHEDRINE", "unii": "7CUC9DDI9F", "classCode": "ACTIB", "strengthNumerator": "60", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "HHT01ZNK31", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (5 MPA.S)", "unii": "R75537T0T4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (10000 MPA.S)", "unii": "0HO1H52958", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "1200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PSEUDOEPHEDRINE", "unii": "7CUC9DDI9F", "classCode": "ACTIB", "strengthNumerator": "120", "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 • temporarily relieves nasal congestion due to: • common cold • hay fever • upper respiratory allergies • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • temporarily relieves sinus congestion and pressure", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Centre right away (1-800 222-1222).", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purposes": "Expectorant Nasal Decongestant", "Warnings": " Do not use 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 extended-release 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: For 600 mg/60 mg: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours For 1200 mg/120 mg: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours • children under 12 years of age: do not use", "Other information": "• Tamper evident: do not use if carton is open or if printed seal on blister is broken or missing. • store between 20-25°C (68-77°F)", "Inactive ingredients": "carbomer homopolymer Type B, cellulose microcrystalline, hypromellose, lake of FD&C yellow 6, magnesium stearate, sodium starch glycolate Type A", "Questions or comments?": "Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST. You may also report side effects to this phone number. Keep the carton. It contains important information. See end panel for expiration date. Manufactured By: Granules India Limited Hyderabad – 500 081, INDIA MADE IN INDIA Distributed By: Granules USA, Inc. Parsippany, NJ 07054", "When using this product": "• do not use more than directed", "Stop use and ask a doctor if": "• you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.", "Ask a doctor before use if you have": "• heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus)", "Active ingredients (in each extended-release tablet)": "(For 600 mg/60 mg) Guaifenesin USP, 600 mg Pseudoephedrine HCL USP, 60 mg (For 1200 mg/120 mg) Guaifenesin USP, 1200 mg Pseudoephedrine HCL USP, 120 mg", "PRINCIPAL DISPLAY PANEL 600 mg and 60 mg - Blister Carton Label": "NDC 62207-827-72 † Compare To the active ingredients of Mucinex ® D Guaifenesin and Pseudoephedrine Hydrochloride FOR DAY OR NIGHT Extended-Release Tablets 12HR 600 mg and 60 mg Guaifenesin 600 mg - Expectorant • Clears Nasal & Sinus Congestion Pseudoephedrine HCl 60 mg - Nasal Decongestant • Thins & Loosens Mucus • Immediate & Extended Release RELIEVES NASAL & CHEST CONGESTION 90 (9x10) Extended-Release Tablets", "PRINCIPAL DISPLAY PANEL 1200 mg and 120 mg - Blister Carton Label": "NDC 62207-828-71 † Compare To the active ingredients of Mucinex ® D Guaifenesin and Pseudoephedrine Hydrochloride FOR DAY OR NIGHT Extended-Release Tablets 12HR 1200 mg and 120 mg Guaifenesin 1200 mg - Expectorant • Clears Nasal & Sinus Congestion Pseudoephedrine HCl 120 mg - Nasal Decongestant • Thins & Loosens Mucus • Immediate & Extended Release RELIEVES NASAL & CHEST CONGESTION 70 (7x10) Extended-Release Tablets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:25.153223 · Updated: 2026-03-14T23:10:50.302579