Label: HEADACHE, CIRCLE K- acetaminophen, caffeine, aspirin tablet tablet
- NDC Code(s): 66715-5438-3
- Packager: Lil' Drug Store Products, Inc.
- This is a repackaged label.
- Source NDC Code(s): 68210-0107
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 14, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purposes
- Uses
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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: 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.
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 olde
- have had stomach ulcers or bleeding problems
- 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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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SPL UNCLASSIFIED SECTION
Product manufactured for:
Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404
www.lildrugstore.com 54383C-US-08-21
Proudly distributed by Circle K Stores Inc.
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Excedrin® Extra Strength. - PDP/Package
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INGREDIENTS AND APPEARANCE
HEADACHE, CIRCLE K
acetaminophen, caffeine, aspirin tablet tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-5438(NDC:68210-0107) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color white (white to off-white, with specks) 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:66715-5438-3 3 in 1 CARTON 09/17/2021 1 6 in 1 POUCH; 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 09/17/2021 Labeler - Lil' Drug Store Products, Inc. (093103646)