Label: VANACOF 2- chlophedianol hcl, dexchlorpheniramine maleate solution
- NDC Code(s): 58809-190-16
- Packager: GM Pharmaceuticals, INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 1, 2024
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- Official Label (Printer Friendly)
- Active ingredients in each 5 mL (1 teaspoonful)
- Purpose
- Uses
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Warnings
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
■ glaucoma
When using this product
■ excitability may occur, especially in children
■ may cause marked drowsiness
■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect
■ avoid alcoholic drinks
■ use caution when driving a motor vehicle or operating machinery
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Directions
do not exceed recommended dosage.
adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teaspoonfuls
(40 mL) in 24 hours.children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls
(20 mL) in 24 hours.children under 6 years of age: consult a doctor. - Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
NDC 58809-190-16
VanaCof® 2
EACH 5 mL (1 TEASPOONFUL) CONTAINS:
Chlophedianol HCI..........................12.5 mg
Dexchlorpheniramine Maleate............1 mg
Cough Suppressant
Antihistamine
Sugar Free, Alcohol Free, Dye Free
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
THIS BOTTLE IS NOT TO BE DISPENSED TO CONSUMER.
Dispense in a tight, light-resistant container with a child-resistant cap.
US Patent # 9,463,191
US Patent # 9,050,289
GM Pharmaceuticals, Inc.
16 fl. oz. (473 mL)
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INGREDIENTS AND APPEARANCE
VANACOF 2
chlophedianol hcl, dexchlorpheniramine maleate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58809-190 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE 1 mg in 5 mL CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE 12.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL SOLUTION (UNII: 8KW3E207O2) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SUCRALOSE (UNII: 96K6UQ3ZD4) GLYCERIN (UNII: PDC6A3C0OX) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) Product Characteristics Color Score Shape Size Flavor RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58809-190-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 12/14/2023 Labeler - GM Pharmaceuticals, INC (793000860)