Label: APRODINE- pseudoephedrine hydrochloride and triprolidine hydrochloride tablet, film coated
- NDC Code(s): 0904-0250-24, 0904-0250-59
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient(s)
Pseudoephedrine HCl 60 mg
Triprolidine HCl 2.5 mgClose
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
itchy, watery eyes
itching of the nose or throat
temporarily relieves nasal congestion due to the common cold
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 rug. 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
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
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful 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 occur with a fever
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
adults and children 12 years and over: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
children under 12 years: do not use this product in children under 12 years of age
- Other information
store at controlled room temperature 15°-30°C (59°-86°F)
see end flap for expiration date and lot number
- Inactive ingredients
corn starch, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silica gel, stearic acid, titanium dioxideClose
- Questions or comments?
To Report Adverse Drug Event Call: (800) 616-2471Close
- Principal Display Panel
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHORIDES
Head Cold & Allergy Medicine Relieves:
• Nasal Congestion • Runny Nose
•Sneezing • Itchy, Watery Eyes
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENE OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
31778 Enterprise Drive
Livonia, MI 48150 USA M-17
Re-Order No. 700796
- INGREDIENTS AND APPEARANCE
pseudoephedrine hcl and tripolidine tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-0250 Route of Administration ORAL DEA Schedule 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 HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 8mm 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 1 24 in 1 BLISTER PACK 2 NDC:0904-0250-59 1 in 1 CARTON 2 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 01/09/1993 Labeler - Major Pharmaceuticals (191427277)