Label: EQUATE SUPHEDRINE PE- phenylephrine hydrochloride tablet
- NDC Code(s): 49035-131-68, 49035-131-89
- Packager: Wal-Mart Stores Inc
- 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.
If you are a consumer or patient please visit this version.
- Active ingredient (in each tablet)
Phenylephrine HCl 10 mgClose
- temporarily relieves sinus congestion and pressure
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
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
- trouble urinating due to an enlarged prostate gland
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- symptoms do not improve within 7 days or are accompanied by 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)
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
do not use this product in children under 12 years of age
- Other information
- store at 20º-25ºC (68º-77ºF)
- 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 dioxideClose
- Questions or comments?
- Principal Display Panel
Compare to Sudafed PE® Congestion Active Ingredient
Phenylephrine HCl Tablets, 10 mg
- INGREDIENTS AND APPEARANCE
EQUATE SUPHEDRINE PE
phenylephrine hydrochloride tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-131 Route of Administration ORAL DEA Schedule 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 CARNAUBA WAX (UNII: R12CBM0EIZ) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) 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) FD&C RED NO. 40 (UNII: WZB9127XOA) 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:49035-131-89 18 in 1 CARTON 1 1 in 1 BLISTER PACK 2 NDC:49035-131-68 36 in 1 CARTON 2 1 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/21/2014 Labeler - Wal-Mart Stores Inc (051957769)