Label: PRO-RED AC- codeine phosphate, dexchorpheniramine maleate, phenylephrine hydrochloride syrup
Contains inactivated NDC Code(s)
NDC Code(s): 66594-499-01, 66594-499-16
- Packager: Pro-Pharma, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CV
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 7, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
Do not exceed recommended dosage.
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
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)
- chronic pulmonary disease or shortness of breath, or children who are taking other drugs
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
When using this product
- may cause or aggravate constipation
- 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
Do not exceed recommended dosage.
Adults and children
12 years of age
(10 mL) every
4 hours, not to
exceed 6 doses in a
to under 12
years of age:
1 teaspoonful (5 mL)
every 4 hours, not
to exceed 6 doses
in a 24 hours.
years of age:
Consult a doctor.
A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.
- Other information
- Inactive ingredients
- Questions? Comments?
Principal display panel and side panel for 473 mL label:
ALCOHOL FREE / SUGAR FREE / GLUTEN FREE
ANTITUSSIVE / ANTIHISTAMINE / NASAL DECONGESTANT
Each teaspoonful (5 mL) contains:
CODEINE PHOSPHATE...........................9 mg
*(WARNING: MAY BE HABIT-FORMING)
Cotton Candy Flavor
16 FL. OZ. (473 mL)
Tamper evident by foil seal under cap. Do not use
if foil seal is broken or missing.
THIS BOTTLE NOT TO BE DISPENSED TO CONSUMER.
Dispense in a tight, light-resistant container with
a child-resistant cap.
Pernix Manufacturing, LLC
Houston, TX 77099
Kirksville, MO 63501
INGREDIENTS AND APPEARANCE
codeine phosphate, dexchorpheniramine maleate, phenylephrine hydrochloride syrup
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66594-499 Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Codeine Phosphate (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) Codeine Phosphate 9 mg in 5 mL DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE 1 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Glycerin (UNII: PDC6A3C0OX) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Sodium Citrate (UNII: 1Q73Q2JULR) Saccharin Sodium (UNII: SB8ZUX40TY) Sorbitol (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor COTTON CANDY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66594-499-16 473 mL in 1 BOTTLE 2 NDC:66594-499-01 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/30/2013 Labeler - Pro-Pharma, LLC (781088146) Registrant - Pernix Manufacturing, LLC (078641814) Establishment Name Address ID/FEI Business Operations Pernix Manufacturing, LLC dba Great Southern Laboratories 078641814 manufacture(66594-499)