NDC | 10202-094-89 |
Set ID | 7e4094aa-93e0-4a88-9744-00ce8d97bdbc |
Category | HUMAN OTC DRUG LABEL |
Packager | 7-Eleven |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active ingredient (in each tablet)
- Purpose
- Uses
- •
- temporarily relieves sinus congestion and pressure
- •
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- 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
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- trouble urinating due to an enlarged prostate gland
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 (1-800-222-1222).
- Directions
adults and children 12 years and over
- •
- take 1 tablet every 4 hours
- •
- do not take more than 6 tablets in 24 hours
children under 12 years
ask a doctor
- Other information
- Inactive ingredients
anhydrous dibasic calcium phosphate, carnauba wax, FD&C red no. 40 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide
Close - Questions or comments?
- Principal Display Panel
Compare to Sudafed PE® Congestion active ingredient
Non-Drowsy
Maximum Strength
Nasal Decongestant PE
Phenylephrine HCl Tablets, 10 mg
Nasal & Sinus Congestion
Sinus Pressure
18 TABLETS
10 mg EACH
Actual Size
Close - INGREDIENTS AND APPEARANCE
7 SELECT NASAL DECONGESTANT PE
phenylephrine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10202-094 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) CARNAUBA WAX (UNII: R12CBM0EIZ) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color RED Score no score Shape ROUND Size 8mm Flavor Imprint Code L7 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10202-094-89 18 in 1 CARTON 10/07/2016 1 1 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 10/07/2016 Labeler - 7-Eleven (007347602)