Label: MAXI-TUSS CD- chlorpheniramine maleate, codeine phosphate, and phenylephrine hydrochloride liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 58605-303-10, 58605-303-16 - Packager: MCR American Pharmaceuticals, Inc.
- 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 August 21, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- nasal congestion
- reduces swelling of nasal passages
- calms the cough control center and relieves coughing
-
Warnings
- Do not exceed recommended dosage.
- A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
- Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a doctor.
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 persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- heart disease
- high blood pressure
- thyroid disease
- diabetes mellitus
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor before use if you are taking sedatives or tranquilizers
When using this product
- excitability may occur, especially in children
- may cause marked drowsiness
- alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic beverages
- use caution 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 over: 1 teaspoonful every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor Children 6 to under 12 years of age: ½ teaspoonful every 4 hours, not to exceed 3 teaspoonfuls in 24 hours, or as directed by a doctor Children under 6 years of age: Consult a doctor - Other information
- Inactive ingredients
- Questions or Comments?
-
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
NDC 58605-303-16
Maxi-Tuss CD
Antihistamine ◾ Cough Suppressant
Nasal DecongestantCV
Each teaspoonful (5 mL) contains:
Chlorpheniramine Maleate 4 mg
Codeine Phosphate 10 mg
Phenylephrine HCl 10 mgGrape Flavor
Alcohol Free ◾ Gluten Free ◾ Sugar Free
Caution: For manufacturing, processing, or
repackaging. This is a bulk container; not
intended for household use.Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.Lot:
Exp Date:16 fl oz (473 mL)
-
INGREDIENTS AND APPEARANCE
MAXI-TUSS CD
chlorpheniramine maleate, codeine phosphate, and phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58605-303 Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg in 5 mL CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 10 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Methylparaben (UNII: A2I8C7HI9T) Potassium Citrate (UNII: EE90ONI6FF) Potassium Sorbate (UNII: 1VPU26JZZ4) Propylparaben (UNII: Z8IX2SC1OH) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Sorbitol (UNII: 506T60A25R) Sucralose (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58605-303-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/2018 2 NDC:58605-303-10 10 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/01/2018 Labeler - MCR American Pharmaceuticals, Inc. (783383011) Establishment Name Address ID/FEI Business Operations MCR American Pharmaceuticals, Inc. 783383011 MANUFACTURE(58605-303)