NDC | 47682-017-33, 47682-017-48, 47682-017-99 |
Set ID | 16fddca9-a66b-41e6-9423-eaf091d3971e |
Category | HUMAN OTC DRUG LABEL |
Packager | Unifirst First Aid Corporation |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
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Drug Facts
Drug Facts
Uses
Temporarily relieves
■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies
■ sinus congestion and pressure
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
■ 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.
Directions
- do not use more than directed
Adults and children: (12 years and older) Take 2 tablets every 4 - 6 hours. Do not take more than 12 tablets in 24 hours.
Children under 12 years: Ask a doctor
Other information
- store at room temperature 59º-86º F (15º-30º C).
- tamper evident sealed packets.
- do not use any opened or torn packets
- Green Guard Allergy 2 Relief Label
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INGREDIENTS AND APPEARANCE
GREEN GUARD ALLERGY 2 RELIEF
phenylephrine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-017 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color red (red) Score no score Shape ROUND (ROUND) Size 7mm Flavor Imprint Code 271 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-017-33 100 in 1 BOX 12/30/2008 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-017-48 250 in 1 BOX 12/30/2008 2 NDC:47682-017-99 2 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:47682-017-99 2 in 1 PACKET; Type 0: Not a Combination Product 12/30/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/30/2008 Labeler - Unifirst First Aid Corporation (832947092) Establishment Name Address ID/FEI Business Operations Prestige Packaging 080667761 relabel(47682-017) , repack(47682-017)