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Drug Facts
Meijer Maximum Strength Sore Throat Fast Relief Spray
FDA Label NDC 41250-764
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc for the product Meijer Maximum Strength Sore Throat Fast Relief (NDC 41250-764). 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 other, active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor or dentist if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Phenol 1.5%
Glycerin 33%
Purpose
Oral Anesthetic/Analgesic
Demulcent
Uses
Temporarily:
▪ relieves occasional minor irritation/discomfort/pain of sore throat and sore mouth▪ protects irritated areas in sore throat and sore mouth
Warnings
Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by a doctor.
When Using This Product
do not exceed recommended dosage.
Stop Use And Ask A Doctor Or Dentist If
▪ sore mouth symptoms do not improve in 7 days▪ irritation, pain or redness persists or worsens▪ swelling, rash or fever develops
If Pregnant Or Breast-Feeding,
ask a doctor before use.
Keep Out Of Reach Of Children.
In case of overdose, or accidental poisoning, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Directions
Adults and children 6 years of age and older:
▪ apply to the affected area (one spray)▪ allow to remain in place for at least 15 seconds, then spit out▪ use every 2 hours or as directed by a doctor or dentist
Children under 12 years of age should be supervised in the use of this product
Children under 6 years of age: consult a doctor or dentist.
Other Information
▪ Store at room temperature.▪ Check expiration date before using
Inactive Ingredients
FD&C blue #1, FD&C red #40, flavor, purified water, sucralose.
Questions Or Comments?
1-866-467-2748
TAMPER- EVIDENT: DO NOT USE IF OUTER BOX IS OPEN.
Principal Display Panel
meijer®
NDC 41250-764-01
Compare to Chloraseptic ® Max active ingredients*
Sore Throat Spray
PHENOL 1.5%
Oral anesthetic & Analgesic
GLYCERIN 33%
Demulcent
Maximum strength
Wild Berry Flavor
Targeted spray, Coats to Protect, Aspirin, Sugar free
1FL OZ (30 mL)
*This product is not manufactured or distributed by Medtech Products Inc., a Prestige brands Co., owner of the registered trademark Chloraseptic®.
Keep this carton for future reference on full labeling.
DIST. BY MEIJER DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
MEIJER PHARMACISTS RECOMMENDED MONEY BACK GUARANTEE
Meijer Sore Throat Spray Maximum Strength (Chloraseptic Sore Throat Spray Max 01)
* Please review the disclaimer below.
