Guaifenesin and Pseudoephedrine HCl Extended-Release Tablets, 600 mg/60 mg and 1200 mg/120 mg

Manufacturer
Granules India Ltd
Effective date
2026-10-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-10-10 01:02:16

Label at a glance#

ProductGuaifenesin and Pseudoephedrine HCl
Active ingredientGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure12 sections

Indications and 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

Dosage and administration

• 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...

Label contents#

Full prescribing information#

Active ingredients (in each extended-release tablet)

OTC - ACTIVE INGREDIENT SECTION

(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

Purposes

OTC - PURPOSE SECTION

Expectorant

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

• 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

Warnings

WARNINGS SECTION

 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• 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)

When using this product

OTC - WHEN USING SECTION

• do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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).

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

WARNINGS SECTION

• 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 INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL 600 mg and 60 mg - Blister Foil Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ggf-pseudo-600mg-60mg-foil-labelggf-pseudo-600mg-60mg-foil-label

PRINCIPAL DISPLAY PANEL 600 mg and 60 mg - Blister Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62207-827-72†Compare To
the active ingredients of
Mucinex ® D

Guaifenesin and
Pseudoephedrine Hydrochloride
FOR DAY OR NIGHT

Extended-Release Tablets12HR

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

ggf-pseudo-600mg-60mg-blistercartonggf-pseudo-600mg-60mg-blistercarton

PRINCIPAL DISPLAY PANEL 1200 mg and 120 mg - Blister Foil Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ggf-pseudo-1200mg-120mg-foil-labelggf-pseudo-1200mg-120mg-foil-label

PRINCIPAL DISPLAY PANEL 1200 mg and 120 mg - Blister Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62207-828-71†Compare To
the active ingredients of
Mucinex ® D

Guaifenesin and
Pseudoephedrine Hydrochloride
FOR DAY OR NIGHT
Extended-Release Tablets12HR

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

ggf-pseudo-1200mg-120mg-blistercartonggf-pseudo-1200mg-120mg-blistercarton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130362207827720GTIN-13: 0362207827720
EAN-13: 0362207827720
GTIN-12: 362207827720
UPC-A: 362207827720
GTIN storage (14 digits): 00362207827720
ggf-pseudo-600mg-60mg-blistercarton.jpg
BarcodeEAN-130362207828710GTIN-13: 0362207828710
EAN-13: 0362207828710
GTIN-12: 362207828710
UPC-A: 362207828710
GTIN storage (14 digits): 00362207828710
ggf-pseudo-1200mg-120mg-foil-label.jpg, ggf-pseudo-1200mg-120mg-blistercarton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62207-82762207-827-72
62207-82862207-828-71

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-12-02full-release2026-06-01 01:19:06

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-22
A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-22c2088c7a36db…
2026-10-15 13:18:302026-09A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-22c2088c7a36db…
2026-09-14 22:38:342026-08A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-2284e616aacf4f…
2026-09-14 22:38:342026-08A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-2284e616aacf4f…
2026-08-18 06:07:402026-07A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-228072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-226a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-221c564ffb4f44…
2024-02-18 07:12 UTC2024-02A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216082-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2022-08-22ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A216082-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2022-08-22ea1830bbd6c7…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
44f2a33c-21a2-28a8-e063-6294a90a50ab75f4ff44-02e7-4a23-a394-85fe8b442e1a2025-12-02WarningsExact identifier
spl set id: 75f4ff44-02e7-4a23-a394-85fe8b442e1a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.