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Effervescent Cold Relief by Tower Laboratories Ltd

Medically reviewed on August 31, 2018

Dosage form: tablet, effervescent
Ingredients: ASPIRIN 325mg, CHLORPHENIRAMINE MALEATE 2mg, PHENYLEPHRINE BITARTRATE 7.8mg
Labeler: Tower Laboratories Ltd
NDC Code: 50201-0246

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

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.

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.

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.

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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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.

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

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

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.

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 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.


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 ingredients:

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

 

EFFERVESCENT COLD RELIEF  
aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50201-0246
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE BITARTRATE (PHENYLEPHRINE) PHENYLEPHRINE BITARTRATE7.8 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ASPARTAME 
CITRIC ACID MONOHYDRATE 
DOCUSATE SODIUM 
MANNITOL 
POVIDONE K30 
SODIUM BENZOATE 
SODIUM BICARBONATE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize25mm
FlavorLEMON (N&A Lemon Lime Flavor FAKP193) Imprint CodeCF
Contains    
Packaging
#Item CodePackage Description
1NDC:50201-0246-12 TABLET, EFFERVESCENT in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2010
Labeler - Tower Laboratories Ltd (001587203)
Registrant - Tower Laboratories Ltd (869024500)
Establishment
NameAddressID/FEIOperations
Tower Laboratories Ltd869024500manufacture(50201-0246)

 
Tower Laboratories Ltd

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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