Label: MAXI-TUSS TR- pseudoephedrine hydrochloride and triprolidine hydrochloride liquid
Contains inactivated NDC Code(s)
NDC Code(s): 58605-305-16
- Packager: MCR American Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- 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.
Updated June 23, 2020
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Do not exceed 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 breathing problem such as emphysema or chronic bronchitis
- heart disease
- high blood pressure
- thyroid disease
- diabetes mellitus
- difficulty in urination due to enlargement of the prostate gland
When using this product
- excitability may occur, especially in children
- may cause drowsiness
- alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or are accompanied by fever
- new symptoms occur
Do not exceed recommended dosage.
Adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 4-6 hours, not to exceed 8 teaspoonfuls in 24 hours Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4-6 hours, not to exceed 4 teaspoonfuls in 24 hours Children under 6 years of age: Consult a physician
- Other information
- Inactive ingredients
- Questions or comments?
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
Nasal Decongestant ◾ Antihistamine
Sugar Free ◾ Alcohol Free ◾ Dye Free
Each teaspoonful (5 mL) for oral administration
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
MCR American Pharmaceuticals, Inc.
Brooksville, FL 34604
16 fl oz (473 mL)
INGREDIENTS AND APPEARANCE
pseudoephedrine hydrochloride and triprolidine hydrochloride liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58605-305 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride 30 mg in 5 mL Triprolidine Hydrochloride (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) Triprolidine Hydrochloride 1.25 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Methylparaben (UNII: A2I8C7HI9T) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) Potassium Citrate (UNII: EE90ONI6FF) Propylparaben (UNII: Z8IX2SC1OH) Propylene Glycol (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Sorbitol (UNII: 506T60A25R) Sucralose (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58605-305-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 08/01/2020 Labeler - MCR American Pharmaceuticals, Inc. (783383011) Establishment Name Address ID/FEI Business Operations MCR American Pharmaceuticals, Inc. 783383011 MANUFACTURE(58605-305)