Label: EFFERVESCENT COLD RELIEF- aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated August 31, 2012
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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
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 DOCTOR/PHARMACIST
DO NOT USE
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
- PREGNANCY OR BREAST FEEDING
- INDICATIONS & USAGE
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 REACTIONS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
EFFERVESCENT COLD RELIEF
aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50201-0246 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ASPARTAME (UNII: Z0H242BBR1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DOCUSATE SODIUM (UNII: F05Q2T2JA0) MANNITOL (UNII: 3OWL53L36A) POVIDONE K30 (UNII: U725QWY32X) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor LEMON (N&A Lemon Lime Flavor FAKP193) Imprint Code CF Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50201-0246-1 2 in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/01/2010 Labeler - Tower Laboratories Ltd (001587203) Registrant - Tower Laboratories Ltd (869024500) Establishment Name Address ID/FEI Business Operations Tower Laboratories Ltd 869024500 manufacture(50201-0246)