Effervescent Cold Relief

Manufacturer
Tower Laboratories Ltd
Effective date
2012-08-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:32:54

Label at a glance#

ProductEffervescent Cold Relief
Active ingredientASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE
Label structure15 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.

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

ADVERSE REACTIONS SECTION

 Adverse Event Reporting: Serious side effects associated with the use of this product can be reported to the following address or by calling the following telephone number.

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1536840aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral TabletPSN5
1536840aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral TabletSCD5
1536840ASA 325 MG / Chlorpheniramine Maleate 2 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral TabletSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
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fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
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b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
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f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
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c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
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42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50201-0246-12020-01-31C16284748780-19d75b9d0-efec-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50201-0246-1Effervescent Cold Relief2 in 1 POUCHTABLET, EFFERVESCENT25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50201-0246EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [TOWER LABORATORIES LTD]5Legacy NDC, 1 package rows20120831_9b1ec246-aec2-4279-baf5-43e63e3c0be1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76E5
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9Z5
PHENYLEPHRINE BITARTRATEACTIVE INGREDIENT27O3Q5ML575
ASPIRINACTIVE MOIETYR16CO5Y76E5
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965U5
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV5
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G95
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR15
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP5
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA05
MANNITOLINACTIVE INGREDIENT3OWL53L36A5
POVIDONE K30INACTIVE INGREDIENTU725QWY32X5
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU5
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QO5

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
50201-024650201-0246-1

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
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGRANULE, FOR SUSPENSION / ORAL6000 mgExact identifier — unii candidate
65 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE, DENTIFRICE / DENTAL0.5 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SUSPENSION / INTRAMUSCULAR71 mgExact identifier — unii candidate
65 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1LOZENGE / ORAL136 mgExact identifier — unii candidate
19 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1CAPSULE, EXTENDED RELEASE / ORAL3 mgExact identifier — unii candidate
19 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPDOUCHE / VAGINAL0.07 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / RESPIRATORY (INHALATION)0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL1568 mgExact identifier — unii candidate
65 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii candidate
35 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
65 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOSOLUTION / RESPIRATORY (INHALATION)2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASPRAY / NASAL41.5 mgExact identifier — unii candidate
65 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRABURSALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION / INTRATHECAL0.05 mgExact identifier — unii candidate
34 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / OPHTHALMIC0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / BUCCALNAExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINSERT / VAGINAL129 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, ORALLY DISINTEGRATING / ORAL107 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
34 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINHALANT / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, COATED / ORALNAExact identifier — unii candidate
88 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, FILM COATED / ORAL245 mgExact identifier — unii candidate
40 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / RECTAL7 mgExact identifier — unii candidate
88 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XSUSPENSION / OPHTHALMIC14 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, SOLUTION / INTRAMUSCULAR4.8 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET / SUBLINGUAL495 mgExact identifier — unii candidate
65 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, FOR SUSPENSION / ORAL462 mgExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XFILM, EXTENDED RELEASE / TRANSDERMAL16 mgExact identifier — unii candidate
40 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR113 mgExact identifier — unii candidate
65 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9LOZENGE / ORAL120 mgExact identifier — unii candidate
17 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / NASAL2.8 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION / INTRAVENOUS15200 mgExact identifier — unii candidate
65 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPFILM / SUBLINGUAL10 mgExact identifier — unii candidate
88 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL78 mgExact identifier — unii candidate
19 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SUSPENSION / INTRAVENOUS2.5 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR300 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, EXTENDED RELEASE / ORAL1086 mgExact identifier — unii candidate
65 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1SUSPENSION / ORAL23 mgExact identifier — unii candidate
19 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / OPHTHALMICADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION / TOPICAL4 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XGRANULE, EFFERVESCENT / ORAL40 mgExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XLOZENGE / ORAL700 mgExact identifier — unii candidate
40 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAVENOUS396 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS608 mgExact identifier — unii candidate
88 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC4.35 %w/wExact identifier — unii candidate
65 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUENEMA / RECTAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, EMULSION / INTRAVENOUS0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / EPIDURAL0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPELIXIR / ORAL100 mg/5mlExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSPRAY, METERED / NASAL2 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii candidate
35 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
b3d1e541-da02-4735-81be-b4a45f045c7b9b1ec246-aec2-4279-baf5-43e63e3c0be12012-08-31Warnings, Adverse reactionsExact identifier
spl id: b3d1e541-da02-4735-81be-b4a45f045c7b
spl set id: 9b1ec246-aec2-4279-baf5-43e63e3c0be1

Reported adverse events (FAERS/openFDA)#

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