Pro-chlo
FDA Label NDC 66594-321

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pro-pharma, Llc for the product Pro-chlo (NDC 66594-321). 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)Chlophedianol HCl 12.5 mgPhenylephrine HCl 5 mgPyrilamine Maleate 12.5 mg

Purpose

AntitussiveNasal DecongestantAntihistamine

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, water eyes

Warnings

Do not exceed recommended dosage.

Do Not Use This Product

  • if you are now taking a prescription monoamine oxidase inhibibor (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.

Ask A Doctor Before Use If You Have

  • a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

Otc - Ask Doctor/Pharmacist

Ask  a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When Using This Product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • be careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.  A persistent cough may be a sign of a serious condition.
  • new symptoms occur

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not exceed recommended dosage.
Adults and
children 12
years of age
and over:
2 teaspoonfuls (10 mL)
every 6 hours, not to
exceed 8 teaspoonfuls in
24 hours
Children 6 to
under 12 years
of age:

1 teaspoonful (5 mL)
every 6 hours, not to
exceed 4 teaspoonfuls in
24 hours
Children under
6 years of age:
Consult a doctor.


Other Information

Store at 59°-86°F (15°-30°C)

Inactive Ingredients

Bitter Mask, Citric Acid, Cotton Candy Flavor, FD&C Red #40, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?

Call 1-660-665-0084

Product Packaging

The packaging below represents the labeling currently used:Principal display panel and side panel for 473 mL label:NDC #66594-321-16PRO-CHLOLIQUIDALCOHOL FREE·GLUTEN FREE·SUGAR FREEANTITUSSIVE · NASAL DECONGESTANT· ANTIHISTAMINEEach teaspoonful (5 mL) contains:CHLOPHEDIANOL HCL...............................12.5 mgPHENYLEPHRINE HCL....................................5 mgPYRILAMINE MALEATE..............................12.5 mgCotton Candy FlavorPATENT PENDING16 FL. OZ. (473 mL)PRO-PHARMA LLCTamper evident by foil seal under cap.  Do not use if foilseal is broken or missing.Dispense in a tight, light-resistant container with a child-resistantcap.THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.Patent PendingManufactured by:Great Southern Laboratories,Houstin, TX  77099Distributed for:Pro-Pharma, LLCKirksville, MO  63501Iss. 10/11

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