M-end Liquid
FDA Label NDC 12830-816

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by R. A. Mcneil Company for the product M-end (NDC 12830-816). 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 drug facts, purpose, uses, warnings, do not use this product, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)
Dexbrompheniramine Maleate 0.667 mg
Dextromethorphan HBr 10 mg
Pseudeophedrine HCl 20 mg

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Directions

Do not exceed 4 doses in a 24 hour period.

Adults and children
12 years of age
and over:

3 teaspoonfuls (15 mL)
every 6 hours, not to
exceed 12 teaspoonfuls
in 24 hours
Children 6 to under
12 years of age:



1 1/2 teaspoonfuls
(7.5 mL) every 6 hours,
not to exceed 6
teaspoonfuls in
24 hours
Children under 6
years of age:
Consult a Physician.

Other Information

Store at 59°-86°F (15°-30°C)

Inactive Ingredients

Bitter Mask, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose, Tutti Frutti Flavor.

Questions? Comments?

Call 1-423-493-9170

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