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NDC 63868-0228-20 Quality Choice Effervescent Cold Relief Plus 325; 2; 7.8 mg/1; mg/1; mg/1 Details
Quality Choice Effervescent Cold Relief Plus 325; 2; 7.8 mg/1; mg/1; mg/1
Quality Choice Effervescent Cold Relief Plus is a ORAL TABLET, EFFERVESCENT in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association. The primary component is ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE.
Product Information
NDC | 63868-0228 |
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Product ID | 63868-228_c1bd1d54-3887-7ca5-e053-2995a90a3f42 |
Associated GPIs | 43994003080830 |
GCN Sequence Number | 065743 |
GCN Sequence Number Description | chlorphenir/phenyleph/aspirin TABLET EFF 2-7.8-325 ORAL |
HIC3 | B5N |
HIC3 Description | 1ST GEN ANTIHIST-DECON-ANALGESIC, SALICYLATE |
GCN | 27781 |
HICL Sequence Number | 036694 |
HICL Sequence Number Description | CHLORPHENIRAMINE MALEATE/PHENYLEPHRINE BITARTRATE/ASPIRIN |
Brand/Generic | Generic |
Proprietary Name | Quality Choice Effervescent Cold Relief Plus |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Aspirin, Chlorpheniramine maleate, and Phenylephrine bitartrate |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET, EFFERVESCENT |
Route | ORAL |
Active Ingredient Strength | 325; 2; 7.8 |
Active Ingredient Units | mg/1; mg/1; mg/1 |
Substance Name | ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE |
Labeler Name | Chain Drug Marketing Association |
Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor An |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part341 |
Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63868-0228-20 (63868022820)
NDC Package Code | 63868-228-20 |
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Billing NDC | 63868022820 |
Package | 10 POUCH in 1 CARTON (63868-228-20) / 2 TABLET, EFFERVESCENT in 1 POUCH |
Marketing Start Date | 2014-01-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 90622927-9682-4eb0-8c7f-894230b3dda4 Details
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
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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. (See note below)
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.
SPL UNCLASSIFIED 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.
SPL UNCLASSIFIED 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 ■ you are taking a diuretic. ■ you are taking sedatives or tranquilizers You have ■ glaucoma ■ diabetes ■ thyroid disease ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ been placed on a sodium-restricted diet
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED 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 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
SPL UNCLASSIFIED SECTION
Stop use and ask a doctor if
■ you experience any of the following signs of stomach bleeding
■ feel faint ■ vomit blood ■ have bloody or black 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 a loss of hearing occurs
■ nervousness, dizziness or sleeplessness occurs
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
QUALITY CHOICE EFFERVESCENT COLD RELIEF PLUS
aspirin, chlorpheniramine maleate, and phenylephrine bitartrate tablet, effervescent |
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Labeler - Chain Drug Marketing Association (011920774) |