Active Ingredients
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin (NSAID*) 250 mg
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Headache, Circle K (NDC 66715-5438). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purposes, uses, reye's syndrome, allergy alert, stomach bleeding warning, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin (NSAID*) 250 mg
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever
Pain reliever
Pain reliever aid
Uses
temporarily relieves minor aches and pains due to:
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: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
adults and children (12 years and over) | take 2 capletsevery 6 hours as needed; not more than 8 caplets in 24 hours |
| children under 12 years | ask a doctor |
Other information
Inactive ingredients colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone K30, pregelatinized starch, stearic acid, talc
Questions or comments?
Call toll-free
1-877-507-6516 (M-F 8 AM-4:30PM CST)
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.
TEMPORARILY RELIEVES HEADACHES
Compare to the active ingredients in
Excedrin® Extra Strength*
CIRCLE K™
extra strength
headache
Acetaminophen 250 mg, Pain Reliever
Aspirin (NSAID) 250 mg, Pain Reliever
Caffeine 65 mg, Pain Reliever Aid
[caplet image]
actual size
6 caplets (2 per pouch)
* Please review the disclaimer below.