NDC 66715-5438OTC monographFDA OTC MONOGRAPH DRUG · M013

Headache, Circle K

Active substance: Acetaminophen, Caffeine, Aspirin tablet

FDA labeler: Lil' Drug Store Products, Inc.

2 formulations • 2 package configurations
All 4 registered NDCs — click to copy
In one line

Headache, Circle K (Acetaminophen, Caffeine, Aspirin tablet) NDC 66715-5438 converts to 66715-5438-03 for billing and bills under J0131 at 10 mg = 1 Unit.

openFDA Live Registry SyncHIPAA 5-4-2 StandardCMS Level II Crosswalk
Listing: 66715-5438
Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

HCPCS Level II J-Code
J0131
Injection, acetaminophen, 10 mg
Billable unit: 10 mg = 1 Unit
11-digit HIPAA NDC
66715-5438-03
Zero-padded 5-4-2 format
Standard conversion
CPT administration code
99213 / Pharmacy
Oral self-administered medication / Office Visit or Pharmacy Claim
UB-04 revenue code
Rev 0636
0636 (Pharmacy - Extension of 0250 Drugs Requiring Detail)
Qualifier: UN

Interactive Unit Multiplier Calculator

J0131

Calculate the exact number of billable HCPCS units to report on CMS-1500 / 837P claims based on the patient dose and single-dose vial waste.

MG
Units to report on claim:
10 Units
Based on 10 mg = 1 billable unit (10.0 exact)
Box 24 / HCPCS Quantity Formatted Line:J0131 UN10 (N46671554383)
Complete drug registry

All registered strengths & packaging

Every registered strength and package for Headache, Circle K, with 10-digit and 11-digit NDC formats
Formulation / rolePackage NDCProduct NDC11-digit HIPAAPackaging detailCopy
250 mg/1, 250 mg/1, 65 mg/166715-5438-366715-543866715-5438-033 POUCH in 1 CARTON (66715-5438-3) / 6 TABLET in 1 POUCH
250 mg/1, 65 mg/1, 250 mg/166715-5506-466715-550666715-5506-041 BOTTLE, PLASTIC in 1 CARTON (66715-5506-4) / 50 TABLET in 1 BOTTLE, PLASTIC
FDA drug label

Prescribing information

Taken from the manufacturer's FDA Structured Product Labeling submission. This is the label as filed, not a summary.

3 Label Sections
Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches sinusitis toothache premenstrual and menstrual cramps
Directions do not use more than directed (see Overdose warning) drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hours children under 12 years: ask a doctor
Reye's Syndrome 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 Allergy alert: Aspirin may cause a severe allergic reaction, which may include: hives facial swelling asthma (wheezing) shock Allergy Alert Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Liver Warning Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Stomach bleeding warning 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 a longer time than directed Caffeine warning Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease 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 have asthma Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription) a prescription drug for diabetes, gout, or arthritis any other drug or are under a doctor’s care for any serious condition a blood thinning (anticoagulant) or steroid drug Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. 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 ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms appear These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. Overdose warning Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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