DayClear SINUS PAIN AND PRESSURE

Manufacturer
GM Pharmaceuticals, INC
Effective date
2016-06-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:05:40

Label at a glance#

ProductDayClear SINUS PAIN AND PRESSURE
Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, CHOLINE SALICYLATE
Label structure10 sections

Indications and uses

temporarily relieves nasal congestion due to common cold, hay fever, and other upper respiratory allergies ▪ nasal congestion ▪ minor aches and pains ▪ headache ▪ temporarily reduces fever ▪ sore throat ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus and make coughs more productive

Dosage and administration

do not exceed recommended dosage. do not take more than 6 doses in any 24-hour period. use enclosed dose cup keep dosage cup with product mL = milliliters adults and children 12 years of age and over: 30mL every 4 hours children under 12 years of age: do not use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DAYCLEAR SINUS PAIN AND PRESSURE- choline salicylate, guaifenesin, phenylephrine hydrochloride liquid

GM Pharmaceuticals, Inc.

--

DayClear Sinus Pain & Pressure

Drug Facts:

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION


Choline Salicylate (NSAID)* 870 mg

Guaifenesin 200 mg

Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Expectorant

Nasal decongestant

*nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

temporarily relieves nasal congestion due to common cold, hay fever, and other upper respiratory allergies

▪ nasal congestion

▪ minor aches and pains

▪ headache

▪ temporarily reduces fever

▪ sore throat

▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

Reye's syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert

Salicylates (NSAIDs) may cause a severe allergic reaction which may include:

▪ hives

▪ rash

▪ shock

▪ skin reddening

▪ facial swelling

▪ asthma (wheezing)

Stomach bleeding warnings

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

▪ are age 60 or older

▪ have had stomach ulcers or bleeding problems

▪ take a blood thinning (anticoagulant) or steroid drug

▪ take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

▪ have 3 or more alcoholic drinks every day while using this product

▪ take more or for a longer time than directed

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

▪ if you have ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever/ fever reducer.

▪ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or 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.

▪ if you have ever had an allergic reaction to this product or any of its ingredients

▪ in children under 12 years of age

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

▪ stomach bleeding warning applies to you

▪ you have a history of stomach problems, such as heartburn or if you have ulcers or bleeding problems

▪ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, diabetes or thyroid disease

▪ you have a cough with excessive phlegm (mucus)

▪ you have difficulty in urination due to enlargement of the prostate gland

▪ you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

▪ you have asthma

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

▪ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout, or arthritis.

▪ under a doctor’s care for any serious condition

▪you are taking a diuretic

Stop use and ask a doctor if

OTC - STOP USE SECTION

▪ an allergic reaction occurs. Seek medical help right away.

▪ pain, cough, or nasal congestion 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

▪ ringing in the ears or a loss of hearing occurs

▪ cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

▪ nervousness, dizziness, or sleeplessness occurs

▪ you experience any of the following signs of stomach bleeding:

▪ feel faint

▪ vomit blood

▪ have bloody or black stools

▪ have stomach pain that does not get better

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use salicylates (NSAID) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed recommended dosage.
  • do not take more than 6 doses in any 24-hour period.
  • use enclosed dose cup
  • keep dosage cup with product
  • mL = milliliters
  • adults and children 12 years of age and over: 30mL every 4 hours
  • children under 12 years of age: do not use

Other information

OTHER SAFETY INFORMATION

  • each 30mL contains: Sodium 12 mg
  • tamper evident: Do not use if foil seal under cap is broken or missing.
  • read all product information before using
  • store at 68° to 86°F (20° to 30°C)
  • avoid excessive heat and humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-888-535-0305 9a.m.- 5p.m. CST

R062716M

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58809-312-08
DayClear
SINUS
PAIN & PRESSURE
8 fl oz (237 mL)

PRINCIPAL DISPLAY PANEL NDC 58809-312-08 DayClear SINUS PAIN & PRESSURE 8 fl oz (237 mL)PRINCIPAL DISPLAY PANEL NDC 58809-312-08 DayClear SINUS PAIN & PRESSURE 8 fl oz (237 mL)

PRINCIPAL DISPLAY PANEL NDC 58809-312-08 DayClear SINUS PAIN & PRESSURE 8 fl oz (237 mL)PRINCIPAL DISPLAY PANEL NDC 58809-312-08 DayClear SINUS PAIN & PRESSURE 8 fl oz (237 mL)

PRINCIPAL DISPLAY PANEL NDC 58809-312-08 DayClear SINUS PAIN & PRESSURE 8 fl oz (237 mL)PRINCIPAL DISPLAY PANEL NDC 58809-312-08 DayClear SINUS PAIN & PRESSURE 8 fl oz (237 mL)

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58809-31258809-312-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
d4a4b843-b48a-42e9-a711-396d2d41b7c534a32f67-31a0-487d-e054-00144ff88e882019-11-18WarningsExact identifier
spl set id: 34a32f67-31a0-487d-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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