Drug Facts
Active ingredients
(in each 5 mL teaspoonful)
Codeine Phosphate 9 mg
*(WARNING: MAY BE HABIT-FORMING)
Dexchlorpheniramine Maleate 1 mg
Phenylephrine Hydrochloride 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Pro-pharma, Llc for the product Pro-red (NDC 66594-499). 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.
Active ingredients
(in each 5 mL teaspoonful)
Codeine Phosphate 9 mg
*(WARNING: MAY BE HABIT-FORMING)
Dexchlorpheniramine Maleate 1 mg
Phenylephrine Hydrochloride 5 mg
Antitussive
Antihistamine
Nasal Decongestant
Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
Do not exceed recommended dosage.
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
If pregnant or breast-feeding, ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
Do not exceed recommended dosage.
| Adults and children 12 years of age and older: | 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 6 doses in a 24 hours. |
Children 6 to under 12 years of age: | 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 doses in a 24 hours. |
Children under 6 | 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.
Store at 59° - 86°F (15° - 30°C)
Citric Acid, Cotton Candy Flavor, FD&C Red #40, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol
Serious side effects associated with use of this product may be reported to this number. 1-660-665-0084
(8 a.m. to 5 p.m.)
CV
Principal display panel and side panel for 473 mL label:
NDC #66594-499-16
CV
PRO-RED AC
SYRUP
ALCOHOL FREE / SUGAR FREE / GLUTEN FREE
ANTITUSSIVE / ANTIHISTAMINE / NASAL DECONGESTANT
Each teaspoonful (5 mL) contains:
CODEINE PHOSPHATE...........................9 mg
*(WARNING: MAY BE HABIT-FORMING)
DEXCHLORPHENIRAMINE
MALEATE...............................................1 mg
PHENYLEPHRINE
HYDROCHLORIDE..................................5 mg
Cotton Candy Flavor
16 FL. OZ. (473 mL)
PRO-PHARMA LLC
"NEW FORMULATION"
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.
Manufactured by:
Pernix Manufacturing, LLC
Houston, TX 77099
Distributed for:
Pro-Pharma, LLC
Kirksville, MO 63501
Rev. 09/13
* Please review the disclaimer below.