Effervescent Cold Relief
Effervescent Cold Relief is an FDA drug label for the active ingredient ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE manufactured by Discount Drug Mart administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20181213.
- Generic name
- ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE
- Manufacturer
- Discount Drug Mart
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 53943-873
- Application
- part341
- Label effective
- 20181213
Active ingredients
Indications & Usage
Uses ■ temporarily relieves these symptoms of the common cold: ■ minor aches and pains ■ headache ■ runny nose ■ fever ■ nasal and sinus congestion ■ sneezing ■ sore throat
Dosage & Administration
Directions ■ do not use more than directed (see overdose warning) ■ adults and children 12 years and over: take 2 tablets fully 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
Contraindications
Not available.
Warnings
Warnings 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: Aspirin may cause a severe 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.
Adverse Reactions
Not available.