Label: CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE liquid
- NDC Code(s): 69367-183-16
- Packager: Westminster Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
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.
Updated July 30, 2021
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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
- runny nose
- itching of the nose or throat
- itchy, watery eyes
- nasal congestion
- reduces congestion
- reduces swelling of nasal passages
Do not exeed 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)
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- heart disease
- high blood pressure
- thyroid disease
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
- use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, diziness, 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 and over: 2 teaspoonfuls every 6 hours, not to exeed 8 teaspoonfuls in 24 hours. children 6 to under 12 years of age: 1 teaspoonful every 6 hours, not to exeed 4 teaspoonfuls in 24 hours. children under 6 years of age: consult a doctor
- Other Information
- Inactive ingredients
- Questions or Comments?
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
Sugar Free, Alcohol Free,
Tutti Frutti Flavor
EACH 5 mL (1 TEASPOONFUL) CONTAINS:
Chlophedianol Hydrochloride 12.5 mg
Dexchlorpheniramine Maleate 1 mg
Pseudoephedrine Hydrochloride 30 mg
16 fl. oz. (473 mL)
INGREDIENTS AND APPEARANCE
CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE
chlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloride liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69367-183 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE 12.5 mg in 5 mL DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE 1 mg in 5 mL PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor FRUIT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69367-183-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/29/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/29/2021 Labeler - Westminster Pharmaceuticals, LLC (079516651)