When treating the common cold, target the root causes of the cold, offering a multi-symptom approach for a quicker recovery.
24-hour support
90% reduction in nasal congestion
Reduction of symptoms in 48 hours
As little as $0 co-pay for commercially insured†
Co-pay discounts automatically applied at 70,000+ participating pharmacies†,‡
†Eligibility restrictions and terms and conditions may apply.
‡Approximate participating pharmacies for eVoucherRx™ and Voucher on Demand™.
IMPORTANT SAFETY INFORMATION For ColdClear
Indications:
ColdClear is indicated for the relief of symptoms associated with the common cold, including nasal congestion,
runny nose, sneezing, sore throat, and coughing.
Warnings:
Allergy Alert: Do not use ColdClear if you have a known allergy
to any of the active ingredients or components of this medication.
Medical Consultation: Consult a healthcare professional before
using ColdClear if you have any underlying medical conditions, including but not limited to heart,
liver, kidney, or respiratory disorders.
Pregnancy and Nursing: ColdClear should not be used by pregnant
or nursing women without medical supervision.
Age Restriction: ColdClear is not recommended for children under
6 years old.
Precautions:
Dosage Instructions: Follow the recommended dosage instructions
provided on the product label. Do not exceed the stated dosage, as it may lead to adverse effects.
Other Medications: Inform your healthcare professional about any
other medications you are taking, as there could be potential interactions with ColdClear.
Driving and Operating Machinery: ColdClear is formulated to be
non-drowsy; however, individual responses may vary. Use caution when driving or operating machinery until
you know how this medication affects you.
Duration of Use: If symptoms persist beyond the recommended duration
of use or worsen, seek medical attention promptly.
Alcohol Interaction: Avoid consuming alcohol while taking ColdClear,
as it may intensify certain side effects.
Side Effects:
Common side effects of ColdClear may include mild dizziness, headache, upset stomach, or mild allergic reactions
(e.g., skin rash, itching). Discontinue use and seek medical attention if any severe allergic reactions occur.
Storage:
Store ColdClear at room temperature, away from direct sunlight, heat, and moisture. Keep out of reach of
children.
Overdose:
In case of accidental overdose or ingestion of more than the recommended amount of ColdClear, seek immediate
medical attention or contact a Poison Control Center.
Important Note:
This ISI summary does not cover all possible precautions, side effects, or drug interactions associated with
ColdClear. For a comprehensive understanding of the medication, carefully read the product label and consult
with a healthcare professional. If you experience any unexpected or severe reactions while using ColdClear,
discontinue use and seek medical assistance promptly.
Manufacturer:
ColdClear Pharmaceuticals, Inc.
Address: [Manufacturer's Address]
Customer Service: [Manufacturer's Customer Service Contact]
Overdose:
In case of accidental overdose or ingestion of more than the recommended amount of ColdClear, seek immediate
medical attention or contact a Poison Control Center.
(Note: The above ISI information is a fictional example and should not be considered as an actual representation
of a real product.)
References:
1. Flynn JT, Kaelber DC, Baker-Smith CM, et al; Subcommittee on Screening and Management of High Blood Pressure in Children. Clinical practice guideline for screening and management of high blood pressure in children. Pediatrics. 2017;140(3):e20171904. 2. [package insert]. Wilmington, MA: Azurity Pharmaceuticals Inc; 2020. 3. Qbrelis [package insert]. Wilmington, MA: Azurity Pharmaceuticals Inc; 2020. 4. Drugs@FDA: FDA-Approved Drugs. Search term: lisinopril. US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process. Accessed January 19, 2023. 5. Gutierrez-Colina AM, Smith AW, Mara CA, Modi AC. Adherence barriers in pediatric epilepsy: from toddlers to young adults. Epilepsy Behav. 2018;80:229-234. 6. Bhosle M, Benner JS, DeKoven M, Shelton J. Difficult to swallow: patient preferences for alternative valproate pharmaceutical formulations. Patient Prefer Adherence. 2009;3:161-171. 7. Chappell F. Medication adherence in children remains a challenge. Prescriber. 2015;26(12):31-34. 8. Zajicek A, Fossler MJ, Barrett JS, et al. A report from the Pediatric Formulations Task Force: perspectives on the state of child-friendly dosage forms. AAPS J. 2013;15(4):1072-1081. 9. Bachynsky J, Wiens C, Melnychuk K. The practice of splitting tablets: cost and therapeutic aspects. Pharmacoeconomics. 2002;20(5):339-346. 10. Gill D, Spain M, Edlund BJ. Crushing or splitting medications: unrecognized hazards. J Gerontol Nurs. 2012;38(1):8-12. 11. US Food and Drug Administration. Guidance for Industry. Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation. March 2013. 12. US Department of Health and Human Services. National Institutes of Health. Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics. https://www.nichd.nih.gov/sites/default/files/inline-files/2020PriorityListFeb20.pdf. Accessed February 13, 2023. 13. McGrady ME, Hommel KA. Medication adherence and health care utilization in pediatric chronic illness: a systematic review. Pediatrics. 2013;132(4):730-740. 14. Matsui D. Current issues in pediatric medication adherence. Pediatr Drugs. 2007;9(5):283-288. 15. Gudeman J, Jozwiakowski M, Chollet J, Randell M. Potential risks of pharmacy compounding. Drugs R D. 2013;13(1):1-8. 16. Allen LV Jr. Amlodipine 1 mg/mL oral liquid. US Pharm. 2014;39(2):55-56. 17. Lisinopril 1-mg/mL oral liquid. Int J Pharm Compound. 2006;10(4):302. 18. US Government Accountability Office. Compounded Drugs: Payment Practices Vary Across Public Programs and Private Insurers, and Medicare Part B Policy Should be Clarified. Report GAO-15-85. October 2014. https://www.gao.gov/products/gao-15-85. Accessed November 2, 2022. 19. US Food and Drug Administration. Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry. January 2018. 20. Watson CJ, Whitledge JD, Siani AM, Burns MM. Pharmaceutical compounding: a history, regulatory overview, and systematic review of compounding errors. J Med Toxicol. 2021;17(2):197-217. 21. Sellers S, Utian WH. Pharmacy compounding primer for physicians: prescriber beware. Drugs. 2012;72(16):2043-2050.
