PRO-RED AC- codeine phosphate, phenylephrine hydrochloride and pyrilamine maleate syrup
Pro-Pharma, LLC
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.
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PRO-RED AC SYRUP
Drug Facts
Active ingredients
(in each 5 mL teaspoonful)
Codeine Phosphate 9 mg
*(WARNING: MAY BE HABIT-FORMING)
Phenylephrine Hydrochloride 5 mg
Pyrilamine Maleate 8.33 mg
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, and, itchy watery eyes
Warnings
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
- a breathing problem such as emphysema or chronic bronchitis
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
When using this product
- excitability may occur, especially in children
- you may get drowsy
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- may cause or aggravate constipation
Directions
Do not exceed recommended dosage.| Adults and children 12 years of age and older: | 1-2 teaspoonfuls (5 mL-10mL) every 4 to 6 hours, not to exceed 4 doses in a 24 hour period. |
| Children 6 to 12 years of age: | 1 teaspoonful (5 mL) every 6 hours, not to exceed 4 doses in a 24 hour period. |
| Children under 6 years of age: | Not recommended for children under 6 years of age. |
Inactive ingredients
Citric Acid, Cotton Candy Flavor, FD&C Red #40, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol
Product Packaging
The packaging below represents the labeling currently used.
Principal display panel and side panel for 473 mL label:
NDC #66594-444-16
CV
PRO-RED AC
SYRUP
ALCOHOL FREE / SUGAR FREE
ANTITUSSIVE / DECONGESTANT / ANTIHISTAMINE
Each teaspoonful (5 mL) contains:
CODEINE PHOSPHATE...........................9 mg
*(WARNING: MAY BE HABIT-FORMING)
PHENYLEPHRINE
HYDROCHLORIDE..................................5 mg
PYRILAMINE MALEATE......................8.33 mg
Cotton Candy Flavor
16 FL. OZ. (473 mL)
Rx PRO-PHARMA
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:
Great Southern Laboratories
Houston, TX 77099
Distributed for:
Pro-Pharma, LLC
Kirksville, MO 63501
Iss. 03/09
| PRO-RED
AC
codeine phosphate, phenylephrine hydrochloride, pyrilamine maleate syrup |
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| Labeler - Pro-Pharma, LLC (781088146) |
| Registrant - Great Southern Laboratories (056139553) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Great Southern Laboratories | 056139553 | manufacture(66594-444) | |