Label at a glance#

ProductDayClear COUGH COLD AND FLU

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, CHOLINE SALICYLATE

Label structure10 sections

Indications and uses

temporarily relieves these common cold and flu symptoms: ▪ cough ▪ nasal congestion ▪ minor aches and pains ▪ sore throat ▪ headache temporarily reduces fever 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 TBSP= tablespoon mL = milliliters adults and children 12 years of age and over: 30mL (2 TBSP) every 4 hours children under 12 years of age: do not use

Contacts and useful links#

PhoneLabel contact1-888-535-0305

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DAYCLEAR COUGH COLD AND FLU- choline salicylate, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

GM Pharmaceuticals, Inc.

--

DayClear COUGH COLD & FLU

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each 30 mL (2 TBSP))

Choline Salicylate (NSAID)*

Dextromethorphan HBr

Guaifenesin

Phenylephrine Hydrochloride

*non-steroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these common cold and flu symptoms:
▪ cough
▪ nasal congestion
▪ minor aches and pains
▪ sore throat
▪ headache
temporarily reduces fever
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 chronic pulmonary disease or shortness of breath
you have a sodium restricted diet

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
taking a diuretic

When using this product do not use more than directed

OTC - WHEN USING SECTION

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 (NSAIDs) 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
TBSP= tablespoon
mL = milliliters
adults and children 12 years of age and over: 30mL (2 TBSP) every 4 hours
children under 12 years of age: do not use

Other information

OTHER SAFETY INFORMATION

each 30mL (2 TBSP) contains: Sodium 11 mg
tamper evident: Do not use if foil seal under cap is broken or missing.
read all product information before using
store at room temperature 59° to 86°F (15°-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

Rev. 06/16

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58809-413-08
DayClear
COUGH

COLD & FLU
8 fl oz (237 mL)

PRINCIPAL DISPLAY PANEL NDC 58809-413-08 DayClear COUGH COLD & FLU 8 fl oz (237 mL)

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

DayClear COUGH COLD AND FLU
Choline Salicylate, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
GUAIFENESIN
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE
CHOLINE SALICYLATE
SALICYLIC ACID
ANHYDROUS CITRIC ACID
GLYCERIN
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SODIUM CITRATE
SACCHARIN SODIUM
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58809-413	58809-413-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
GUAIFENESIN	495W7451VQ	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
CHOLINE SALICYLATE	KD510K1IQW	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SORBITOL	506T60A25R	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
63d19b0f-4182-419f-a2de-d3c6e4ef533f			349eb2ab-f209-2c66-e054-00144ff8d46c	2019-11-18	Warnings	Exact identifier spl set id: 349eb2ab-f209-2c66-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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