Label: EXTRA STRENGTH HEADACHE, CIRCLE K- acetaminophen/aspirin/caffeine tablet tablet
EXTRA STRENGTH HEADACHE- acetaminophen/aspirin/caffeine tablet tablet
- NDC Code(s): 66715-5506-4, 66715-6922-4
- Packager: Lil' Drug Store Products, Inc.
- This is a repackaged label.
- Source NDC Code(s): 68210-0107, 68210-4094
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 31, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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.
- DOSAGE & ADMINISTRATION
- Other information
- INACTIVE INGREDIENT
- QUESTIONS
- PDP (Lil' Drug)
- PDP (CK)
-
INGREDIENTS AND APPEARANCE
EXTRA STRENGTH HEADACHE, CIRCLE K
acetaminophen/aspirin/caffeine tablet tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-5506(NDC:68210-4094) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg Inactive Ingredients Ingredient Name Strength TALC (UNII: 7SEV7J4R1U) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE K30 (UNII: U725QWY32X) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color white (white to off-white with specs) Score no score Shape OVAL (capsule-shaped biconvex) Size 18mm Flavor Imprint Code S53 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-5506-4 1 in 1 CARTON 09/24/2021 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 09/24/2021 EXTRA STRENGTH HEADACHE
acetaminophen/aspirin/caffeine tablet tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-6922(NDC:68210-0107) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg Inactive Ingredients Ingredient Name Strength TALC (UNII: 7SEV7J4R1U) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE K30 (UNII: U725QWY32X) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color white (white to off-white with specs) Score no score Shape OVAL (capsule-shaped biconvex) Size 18mm Flavor Imprint Code S53 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-6922-4 1 in 1 CARTON 09/24/2021 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 09/24/2021 Labeler - Lil' Drug Store Products, Inc. (093103646)