Meijer Menthol Cough Drops
FDA Label NDC 41250-078
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 Menthol Cough Drops (NDC 41250-078). 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 meijer menthol cough drops, active ingredient (in each drop), purpose, uses, warnings sore throat warning:, ask a doctor before use if you have:, when using this product, stop use and consult doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Drop)
Menthol 5.4 mg
Purpose
Cough suppressant/Oral anesthetic
Uses
temporarily relieves:
- cough as may occur with a cold
- occasional minor irritation and sore throat
Warnings Sore Throat Warning:
if sore throat is severe, persists for more than 2 days, is accompanied or followed be fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.
Ask A Doctor Before Use If You Have:
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough accompanied by excessive phlegm (mucus)
When Using This Product
- do not exceed recommended dosage
Stop Use And Consult Doctor If
- cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
- sore throat is severe, or irritation, pain or redness lasts or worsens
- sore mouth does not improve in 7 days
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep This And All Drugs Out Of The Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
| adults and children 5 years and over | allow 1 drop to dissolve slowly in mouth. May be replaced every two hours as necessary or as directed by a doctor. |
| children under 5 years | ask a doctor |
Other Information:
- 10 calories per drop
Inactive Ingredients:
Blue fakes (FD&C blue no.1, glycerin, gum arabic, potassium sorbate), eucalyptus oil, FD&C
blue no. 1, FD&C red no. 40, glucose syrup, natural favoring, sucrose and water. Soybean oil and corn starch used as
processing aids.
Questions?
Or to report an adverse event call 1-800-245-2898. Monday - Friday, 9AM to 4PM EST
Other
MADE IN THE U.S.A.
DIST. BY: MEIJER DISTRIBUTION, INC.
2929 WALKER AVE., NW
GRAND RAPPIDS, MI 49544
www.meijer.com
UD GF Gluten-Free
*This product is not manufactured or distributed by Mondelez Global LLC, owner of the registered trademark Halls®, or by any of its afliates.
Meijer Menthol Cough Drops 200 Count (41250-078-00)
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