Label: APRODINE- pseudoephedrine hcl and tripolidine tablet, film coated
- NDC Code(s): 71205-100-24
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 0904-0250
- 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.
Drug Label Information
Updated October 1, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each tablet)
- Purpose
- Uses
-
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
- •
- trouble urinating due to an enlarged prostate gland
When using this product
- •
- do not exceed recommended dose
- •
- excitability may occur, especially in children
- •
- drowsiness may occur
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- avoid alcoholic drinks
- •
- alcohol, sedatives and tranquilizers may increase drowsiness
- •
- be careful when driving a motor vehicle or operating machinery
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
MAJOR®
NDC 71205-100-24
Aprodine™
TABLETSTRIPROLIDINE HCl AND PSEUDOEPHEDRINE HCl
DECONGESTANT/ANTIHISTAMINE/FILM COATEDHead Cold & Allergy Medicine
Relieves:
• Nasal Congestion • Runny Nose
• Sneezing • Itchy, Watery Eyes24 TABLETS
TAMPER EVIDENT: DO NOT USE IF
CARTON IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING50844 REV0612M17808
Distributed by
MAJOR® PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA M-17Relabeled by
Proficient Rx LP
Thousand Oaks, CA 91320
Re-Order No. 700796
Rev. 09/13 -
INGREDIENTS AND APPEARANCE
APRODINE
pseudoephedrine hcl and tripolidine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-100(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 HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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:71205-100-24 1 in 1 CARTON 09/04/2018 1 24 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/09/1993 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 RELABEL(71205-100)