Capron Dm Liquid
FDA Label NDC 29978-127

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Capital Pharmaceutical, Llc for the product Capron Dm (NDC 29978-127). 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, purpose, uses, warnings, do not use this product, ask a doctor before use if you have, ask a doctor before use if you are taking, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

(in each 5 mL teaspoonful)

Dextromethorphan HBr 7.5 mg      

(in each 5 mL teaspoonful)

Pyrilamine Maleate 7.5 mg

Purpose

Antitussive

Antihistamine

Uses

temporarily relieves these symptoms due to 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 associated with a cold
  • alleviates cough to help you sleep
  • nonnarcotic cough suppressant for the relief of cough

Warnings

Do not exceed recommended dosage.

  • a persistent cough may be a sign of a serious condition. If cough persist for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

Do Not Use This Product

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
  • for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor

Ask A Doctor Before Use If You Have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Before Use If You Are Taking

sedatives or tranquilizers.

When Using This Product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • sedatives and tranquilizers may increase drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:4 teaspoonfuls every 6-8 hours, not to exceed 16 teaspoonfuls in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age:2 teaspoonfuls every 6-8 hours, not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor
Children 2 to under 6 years of age
(For Professional Use Only)		1 teaspoonful every 6-8 hours, not to exceed 4 teaspoonfuls in 24 hours, or as directed by a doctor
Children under 2 years of age:Consult a doctor

Inactive Ingredients

Citric Acid, Flavor, Magnasweet, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol, Sucralose

Questions Or Comments?

Call 614.638.4622      

Principal Display Panel

NDC 29978-127-16
Capron DM
Liquid
Candy Apple Flavor
16 oz. (473 mL)

NDC 29978-127-15
Capron DM
Liquid
Candy Apple Flavor
15 mL

Principal Display Panelndc 29978-127-15capron Dmliquidcandy Apple Flavor15 mL (Capron Dm Liquid 02)

Principal Display Panelndc 29978-127-15capron Dmliquidcandy Apple Flavor15 mL (Capron Dm Liquid 02)

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