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NDC 63868-0568-20 Quality Choice Effervescent Cold Relief - Orange 325; 2; 7.8 mg/1; mg/1; mg/1 Details
Quality Choice Effervescent Cold Relief - Orange 325; 2; 7.8 mg/1; mg/1; mg/1
Quality Choice Effervescent Cold Relief - Orange 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 | 63868-0568 |
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Product ID | 63868-568_b595318a-0bef-ac72-e053-2995a90a78db |
Associated GPIs | |
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 - Orange |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Aspirin, Chlorpheniramine maleate, 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 63868-0568-20 (63868056820)
NDC Package Code | 63868-568-20 |
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Billing NDC | 63868056820 |
Package | 10 POUCH in 1 CARTON (63868-568-20) / 2 TABLET, EFFERVESCENT in 1 POUCH |
Marketing Start Date | 2020-06-15 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9f7d76f0-4f1c-a1c7-e053-2a95a90a3dca Details
Active ingredients
Purpose
Uses
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 an 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 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.
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. ■ if you ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
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
If pregnant or breast-feeding
SPL UNCLASSIFIED SECTION
Directions
Other information
Inactive ingredients
INGREDIENTS AND APPEARANCE
QUALITY CHOICE EFFERVESCENT COLD RELIEF - ORANGE
aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent |
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Labeler - Chain Drug Marketing Association (011920774) |