FDA.reportPublic FDA data

Mucus Relief D

Manufacturer
CVS Health Corp
Effective date
2025-12-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:21:47

Label at a glance#

ProductMucus Relief D
Active ingredientGuaifenesin, Pseudoephedrine Hydrochloride
Label structure10 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 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: 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age: do not use

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredients (in each extended-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin USP, 1200 mg................................................................................Expectorant

Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant 

Purpose

OTC - PURPOSE SECTION

Expectorant and 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

OTC - DO NOT USE SECTION

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 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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not crush, chew, or break 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: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
  • children under 12 years of age: do not use

Other information

SPL UNCLASSIFIED 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

FD & C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide.

Questions?

OTC - QUESTIONS SECTION

call 1-888-375-3784

You may also report side effect to this phone number.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaifenesin and Pseudoephedrine HCl ER Tablets 1200 mg/120 mg:

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1244675guaiFENesin 1200 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN7
124467512 HR guaifenesin 1200 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-211-24Mucus Relief D4 in 1 CARTONTABLET, EXTENDED RELEASE47
69842-211-24Mucus Relief D6 in 1 BLISTER PACKTABLET, EXTENDED RELEASE67
69842-211-28Mucus Relief D2 in 1 CARTONTABLET, EXTENDED RELEASE27
69842-211-28Mucus Relief D12 in 1 BLISTER PACKTABLET, EXTENDED RELEASE127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-211-24EA - Each69842-2116a2d4bff-f6c9-41da-a97e-725f52b5455412019-12-10
55111-799-24EA - Each55111-799e4586115-733d-4288-a34c-4dca900065d012019-11-12

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-21169842-211-24, 69842-211-28
55111-799

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
Guaifenesin495W7451VQACTIB
Pseudoephedrine Hydrochloride6V9V2RYJ8NACTIB
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POVIDONEFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

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 43.

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
A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-29
A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-29

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-2984e616aacf4f…
2026-09-14 22:38:342026-08A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-2984e616aacf4f…
2026-08-18 06:07:402026-07A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208369-001GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORAL2017-12-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208369-002GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORAL2017-12-2974a2ff9319b5…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief DGUAIFENESIN AND PSEUDOEPHEDRINE HCLCVS Health Corp19cde6f8-649a-df69-7ee9-05da2cccba5b2025-12-10WarningsExact identifier
ndc (package): 69842-211-28
ndc (package): 69842-211-24
ndc (product): 69842-211
ndc11 (package): 69842021124
ndc11 (package): 69842021128
spl id: 6325e827-fe80-4355-2e69-d4952b9e6030
spl set id: 19cde6f8-649a-df69-7ee9-05da2cccba5b
Guaifenesin and Pseudoephedrine HCLGUAIFENESIN AND PSEUDOEPHEDRINE HCLDr. Reddys Laboratories Limited845a2dcc-9069-3141-ae13-f2063f36d1302025-10-24WarningsExact identifier
ndc (product): 55111-799

Reported adverse events (FAERS/openFDA)#

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