Label: PRO-CLEAR AC- codeine phosphate and pyrilamine maleate syrup
Contains inactivated NDC Code(s)
NDC Code(s): 66594-333-01, 66594-333-16
- 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 December 2, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
(in each 5 mL teaspoonful)
Codeine Phosphate* 9 mg
*WARNING: May be habit forming.
Pyrilamine Maleate 8.33 mg
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
- trouble urinating due to an enlarged prostate gland
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
- a cough 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.
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.
years of age
2 teaspoonfuls (10 mL)
every 4 hours, not to
exceed 6 doses in 24 hours.
to under 12
years of age:
1 teaspoonful (5 mL)
every 4 hours, not to
exceed 6 doses in 24 hours
years of age:
Consult a doctor.
- Other information
- Inactive ingredients
- Questions? Comments?
The packaging below represents the labeling currently used.
Principal display panel and side panel for 473 mL label:
NDC # 66594-333-16
SUGAR FREE · DYE FREE · ALCOHOL FREE · GLUTEN FREE
ANTITISSIVE · ANTIHISTAMINE
Each teaspoonful (5 mL) contains:
CODEINE PHOSPHATE*.............................9 mg
*(WARNING: MAY BE HABIT-FORMING)
PYRILAMINE MALEATE..........................8.33 mg
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.
Dispense in a tight, light-resistant container with a child-resistant cap.
THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.
Great Southern Laboratories,
Houston, TX 77099
Kirksville, MO 63501
INGREDIENTS AND APPEARANCE
codeine phosphate and pyrilamine maleate syrup
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66594-333 Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520) Codeine Phosphate 9 mg in 5 mL Pyrilamine Maleate (UNII: R35D29L3ZA) (Pyrilamine - UNII:HPE317O9TL) Pyrilamine Maleate 8.33 mg in 5 mL Inactive Ingredients Ingredient Name Strength Citric Acid (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:66594-333-01 30 mL in 1 BOTTLE 2 NDC:66594-333-16 473 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/08/2008 Labeler - Pro-Pharma LLC (781088146) Registrant - Great Southern Laboratories (056139553) Establishment Name Address ID/FEI Business Operations Great Southern Laboratories 056139553 manufacture