Effervescent Cold Relief

Manufacturer
Cardinal Health, Inc | United Exchange Corporation | Tower Laboratories Ltd
Effective date
2012-09-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:45:41

Label at a glance#

ProductEffervescent Cold Relief
Active ingredientASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each effervescent tablet)                              Purpose

Aspirin 325 mg NSAID*..........................................                 Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg ...............................                 Antihistamine
Phenylephrine Bitartrate 7.8 mg ...............................                 Nasal decongestant

*Nonsteroidal anti-inflammatory drug

WARNINGS SECTION

Warnings

Reye's syndrome: Children and teenagers should not use this drug for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

Allergy alert: Aspirin may cause a server allergic reaction which may include: - hives - facial swelling - asthma (wheezing) - shock

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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 nonprescription 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.

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers.  Aspirin may cause stomach bleeding. 

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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if - stomach bleeding warning applies to you - you have a history of stomach problems, such as heartburn - you have high blood pressure, heart disease, liver cirrhosis, or kidney disease - glaucome - diabetes - thyroid disease - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema or chronic bronchitis - you are taking a diuretic - been placed on a sodium-restricted diet.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are:

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

OTC - DO NOT USE SECTION

Do not use - if you have ever had an allergic reaction to any other pain reliever/fever reducer - if you are allergic to aspirin - 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 - 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 Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.  It is especially important not to use aspirin 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.

OTC - PURPOSE SECTION

Fast Relief of: Nasal Congetion, Runny Nose, Sneezing, Headache, Sinus Pain and Pressure

INDICATIONS & USAGE SECTION

Uses:temporarily relieves these symptoms of the common cold:

- fever - sneezing - nasal congestion - sore throat - headache - minor aches and pains - runny nose - sinus congestion and pressure

OTC - STOP USE SECTION

Stop use and ask a doctor if - you experience any of the following signs of stomach bleeding - feel faint - vomit blood - have bloody stools - have stomach pain that does not get better - an allergic reaction occurs, seek medical help right away. - pain or nasal congestion gets worse or lasts more than 7 days. - fever gets worse or lasts more than 3 days. - new symptoms occur - redness or swelling is present - ringing in the ears or loss of hearing occurs - nervousness, dizziness or sleeplessness occurs.

OTC - WHEN USING SECTION

When using this product:

- do not take more than 8 tablets (adults and children 12 years and over) in a 24-hour period or as directed by a doctor.
- do not use more than directed
- you may get drowsy
- avoid alcoholic drinks
- excitability may occur, especially in children
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery

DOSAGE & ADMINISTRATION SECTION

Directions

- do not use more than directed (see overdose warning)
- adults and children 12 years and over: take 2 tablets completely dissolved in 4 ounces of water every 4-6 hours
- do not take more than 8 tablets in 24 hours

- children under 12 years: ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients:

acesulfame potassium, aspartame, citric acid, docusate sodium, mannitol, povidone, sodium benzoate, sodium bicarbonate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of cartonimage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130096295110241GTIN-13: 0096295110241
EAN-13: 0096295110241
GTIN-12: 096295110241
UPC-A: 096295110241
GTIN storage (14 digits): 00096295110241
leader effervescent cold relief carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37205-218-602025-04-08C16284748780-19d75b9d0-884b-f424-e053-dadaa90a57ceDrug Facts
37205-218-602020-01-31C16284748780-19d75b9d0-884b-f424-e053-dadaa90a57ceDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-218-60EA - Each37205-218f34038cf-eeee-4dfd-a316-a39d85ee612312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76E3
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9Z3
PHENYLEPHRINE BITARTRATEACTIVE INGREDIENT27O3Q5ML573
ASPIRINACTIVE MOIETYR16CO5Y76E3
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965U3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV3
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G93
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR13
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP3
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA03
MANNITOLINACTIVE INGREDIENT3OWL53L36A3
POVIDONE K30INACTIVE INGREDIENTU725QWY32X3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU3
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QO3

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
37205-21837205-218-60

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 309 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MANNITOLMANNITOL3OWL53L36ASUSPENSION/ DROPS / OPHTHALMIC3.3 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGRANULE / ORAL1328 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AWAFER / ORAL642 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / AURICULAR (OTIC)0.04 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION / INTRAVENOUS15200 mgExact identifier — unii candidate
65 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XSUSPENSION, EXTENDED RELEASE / ORAL474 mgExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XLOZENGE / ORAL700 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, COATED / ORAL10.6 mgExact identifier — unii candidate
34 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSWAB / TOPICAL0.05 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9SOLUTION / DENTAL0.12 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, COATED / ORAL177.7 mgExact identifier — unii candidate
65 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET / SUBLINGUAL13 mgExact identifier — unii candidate
17 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / OPHTHALMICADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, FILM COATED, EXTENDED RELEASE / ORAL45 mgExact identifier — unii candidate
40 equally ranked IID candidates
DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0SUSPENSION / ORAL48 mgExact identifier — unii candidate
11 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, FILM COATED / ORAL42 mgExact identifier — unii candidate
88 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGRANULE, FOR SUSPENSION / ORAL6000 mgExact identifier — unii candidate
65 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
17 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ALOZENGE / ORAL20546 mgExact identifier — unii candidate
65 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XCAPSULE, DELAYED RELEASE PELLETS / ORAL178 mgExact identifier — unii candidate
40 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TABLET, EFFERVESCENT / ORAL4 mgExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAVENOUS396 mgExact identifier — unii candidate
88 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, FILM COATED / ORAL2309 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET / SUBLINGUAL495 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION / INTRAMUSCULAR106.6 mgExact identifier — unii candidate
65 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / ORAL269 mgExact identifier — unii candidate
88 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS35 mgExact identifier — unii candidate
65 equally ranked IID candidates
DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0CAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / IONTOPHORESIS0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TROCHE / ORAL26 mgExact identifier — unii candidate
17 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36APOWDER, FOR SUSPENSION / ORAL7093 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
65 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARNAExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOCAPSULE, DELAYED RELEASE PELLETS / ORAL4 mgExact identifier — unii candidate
34 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1SOLUTION / ORAL40 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOCAPSULE / ORAL320 mgExact identifier — unii candidate
34 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASPRAY / NASAL41.5 mgExact identifier — unii candidate
65 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / BUCCALNAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / VAGINAL0.49 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS3219 mgExact identifier — unii candidate
34 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / INTRAVENOUS0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii candidate
88 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9POWDER, FOR SUSPENSION / ORAL45 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR164 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SOLUTION / SUBMUCOSAL2.94 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPELIXIR / ORAL100 mg/5mlExact identifier — unii candidate
88 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XSYSTEM / TRANSDERMAL15 mgExact identifier — unii candidate
40 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGRANULE, FOR SUSPENSION / ORAL113 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION/ DROPS / ORAL19 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLOTION / TOPICAL0.85 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE / ORAL1562 mgExact identifier — unii candidate
65 equally ranked IID candidates

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
4ac2b49e-4dd4-4934-a435-6596d41f42aee6929f35-22e3-45b6-9ae8-5cea27467ac72025-04-07WarningsExact identifier
spl set id: e6929f35-22e3-45b6-9ae8-5cea27467ac7

Reported adverse events (FAERS/openFDA)#

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