FDA.reportPublic FDA data

MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF

Manufacturer
CVS Pharmacy, Inc. | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2026-03-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:51:36

Label at a glance#

ProductMAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF
Active ingredientGUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each softgel)
Daytime Sinus Relief
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Active ingredients (in each softgel)
Nighttime Sinus Relief
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCI 5 mg

OTC - PURPOSE SECTION

Purposes
Daytime Sinus Relief
Pain reliever
Cough suppressant
Expectorant
Nasal decongestant

Purposes
Nighttime Sinus Relief
Pain reliever
Cough suppressant
Antihistamine
Nasal decongestant

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves:

- nasal congestion

- headache

- cough

- minor aches and pains

- sinus congestion and pressure
- runny nose and sneezing (NIGHTTIME only)

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

WARNINGS SECTION

WARNINGS
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 12 softgels in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

OTC - DO NOT USE SECTION

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • glaucoma ( NIGHTTIME only)
  • breathing problems such as emphysema or chronic bronchitis ( NIGHTTIME only)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers ( NIGHTTIME only)

OTC - WHEN USING SECTION

When using this product

  • do not use more than directed
  • excitability may occur, especially in children ( NIGHTTIME only)
  • marked drowsiness may occur (NIGHTTIME only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHTTIME only)
  • avoid alcoholic drinks (NIGHTTIME only)
  • be careful when driving a motor vehicle or operating machinery (NIGHTTIME only)

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with fever, rash, or headache that lasts.

These could be signs of a serious condition.

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.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than directed (see Overdose warning)
  • do not take more than 12 softgels in any 24-hour period
  • adults and children 12 years of age and older: take 2 softgels every 4 hours
  • children under 12 years of age: do not use

OTHER SAFETY INFORMATION

Other information

  • store at 20-25°C (68-77°F)
  • avoid excessive heat

INACTIVE INGREDIENT SECTION

Inactive ingredients (DAYTIME only)
FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, purified water.

Inactive ingredients (NIGHTTIME only)
FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, purified water

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS 630T Daytime Nighttime Sinus Relief

CVS 630T 24ct SRCVS 630T 24ct SR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2634364{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } PackGPCK4
26343641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackPSN4
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSN4
1656815acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSN4
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD4
1656815acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD4
26343641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackSY4
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY4
1656815APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-442-242025-02-13C16284748780-12cef2736-832b-d83d-e063-dadaa90ab31f630T CVS 69842-442 MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF
69842-442-242025-01-30C16284748780-12cef2736-832b-d83d-e063-dadaa90ab31f630T CVS 69842-442 MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-290-08MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED86.25 mg4
69842-442-24MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF1 in 1 CARTONKIT14
69842-442-24MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF1 in 1 BLISTER PACKKIT14
69842-617-16MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF16 in 1 BLISTER PACKCAPSULE, LIQUID FILLED165 mg4

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-44269842-442-24
69842-61769842-617-16
69842-29069842-290-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
FD&C YELLOW NO. 6H77VEI93A8IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GLYCERINPDC6A3C0OXIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SHELLAC46N107B71OIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
GELATIN2G86QN327LIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
POVIDONEFZ989GH94EIACT
WATER059QF0KO0RIACT
ACETAMINOPHEN362O9ITL9DACTIB
SHELLAC46N107B71OIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT

Source Document#

Source XML

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
MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEFACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL AND ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCLCVS Pharmacy, Inc.c17d5ba7-3302-7931-e053-2a95a90a5a6c2026-03-26WarningsExact identifier
ndc (package): 69842-442-24
ndc (package): 69842-617-16
ndc (package): 69842-290-08
ndc (product): 69842-442
ndc11 (package): 69842044224
ndc11 (package): 69842029008
ndc11 (package): 69842061716
spl id: 4de8f8ce-ac96-9aa5-e063-6294a90adb85
spl set id: c17d5ba7-3302-7931-e053-2a95a90a5a6c

Reported adverse events (FAERS/openFDA)#

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