Aspirin, Chlorpheniramine Maleate, Phylephrine Bitartrate

FDA Drug Profile — Dollar General Effervescent Cold Relief, Effervescent Cold Relief

Drug Details

Generic Name
Aspirin, Chlorpheniramine Maleate, Phylephrine Bitartrate
Brand Names
Dollar General Effervescent Cold Relief, Effervescent Cold Relief
Application Number
M012
Sponsor
DOLGENCORP, LLC
NDC Codes
2
Dosage Forms
TABLET, EFFERVESCENT
Routes
ORAL
Active Ingredients
ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE

Indications and Usage

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

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.