Label: APRODINE- pseudoephedrine hcl and triprolidine hcl tablet, film coated
- NDC Code(s): 0904-0250-24, 0904-0250-59
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 13, 2023
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- Official Label (Printer Friendly)
- Active ingredients (in each tablet)
- Purpose
- Uses
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Warnings
Do not use
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
- high blood pressure
- heart disease
- thyroid disease
- diabetes
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- use caution when driving a motor vehicle or operating machinery
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives and tranquilizers may increase drowsiness
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
MAJOR®
NDC 0904-0250-24
Maximum Strength
Aprodine™ TabletsPseudoephedrine HCl 60 mg
Triprolidine HCl 2.5 mg60 mg/2.5 mg
Nasal Decongestant/Antihistamine
Relieves Nasal Congestion,
Sneezing, Runny Nose,
Itchy, Watery EyesActual Size
24 Tablets
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
50844 REV0719N17808
Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152Rev. 11/19 M-17
Re-order No. 700796Major 44-178
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INGREDIENTS AND APPEARANCE
APRODINE
pseudoephedrine hcl and triprolidine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-0250 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE 2.5 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score 2 pieces Shape ROUND Size 7mm Flavor Imprint Code 44;178 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-0250-24 1 in 1 CARTON 01/09/1993 05/05/2024 1 24 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0904-0250-59 1 in 1 CARTON 01/09/1993 05/05/2024 2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 01/09/1993 05/05/2024 Labeler - Major Pharmaceuticals (191427277) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(0904-0250) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(0904-0250) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(0904-0250) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(0904-0250) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(0904-0250)