![MAXI-TUSS CD (CHLORPHENIRAMINE MALEATE, CODEINE PHOSPHATE, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]](https://medic.hrt.org//dailymed/images/e03294a3-1b3e-4d24-ac35-eca00a19db3d/maxituss-01.jpg)
| NDC | 58605-303-10, 58605-303-16 |
| Set ID | e03294a3-1b3e-4d24-ac35-eca00a19db3d |
| Category | HUMAN OTC DRUG LABEL |
| Packager | MCR American Pharmaceuticals, Inc. |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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
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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?
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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)
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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)