Label: SUPHEDRINE PE- phenylephrine hcl tablet, film coated
-
Contains inactivated NDC Code(s)
NDC Code(s): 63981-453-69 - Packager: COSTCO WHOLESALE CORPORATION
- 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 September 21, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- 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
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of the reach of children.
- Directions
- Other information
- Inactive ingredients
-
PRODUCT PACKAGING
The product packaging shown below represents a sample of that currently in use. Additional packaging may aslo be available.
KIRKLAND
Signature™
COMPARE TO
SUDAFED PE™
active ingredient*
NDC 63981-453-69
ITEM # 111266
NON-DROWSY
SUPHEDRINE PE
Phenylephrine Hydrochloride 10 mg
Nasal & Sinus Decongestant Formula
Temporary Relief of:
√ Nasal Congestion
√ Sinus Pressure & Congestion
√ Hay Fever Symptoms
Actual Size
1 Pill Per Dose
144
TABLETS
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
50844 REV0810F45369
Manufactured by:
LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788 USA
For Costco Wholesale Corporation
P.O. Box 34535
Seattle, WA 98124-1535 USA
1-800-774-2678
-
INGREDIENTS AND APPEARANCE
SUPHEDRINE PE
phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63981-453 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 Croscarmellose Sodium (UNII: M28OL1HH48) Dextrose Monohydrate (UNII: LX22YL083G) Dibasic Calcium Phosphate Dihydrate (UNII: O7TSZ97GEP) Fd&c Red No. 40 (UNII: WZB9127XOA) Magnesium Stearate (UNII: 70097M6I30) Maltodextrin (UNII: 7CVR7L4A2D) Cellulose, Microcrystalline (UNII: OP1R32D61U) Silicon Dioxide (UNII: ETJ7Z6XBU4) Carboxymethylcellulose Sodium (UNII: K679OBS311) Trisodium Citrate Dihydrate (UNII: B22547B95K) Product Characteristics Color RED Score no score Shape ROUND Size 6mm Flavor Imprint Code 44;453 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63981-453-69 1 in 1 CARTON 1 144 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/06/2004 Labeler - COSTCO WHOLESALE CORPORATION (103391843) Registrant - L.N.K. International, Inc. (832867837) Establishment Name Address ID/FEI Business Operations L.N.K. International, Inc 832867894 MANUFACTURE