Label: GREEN GUARD ALLERGY 2 RELIEF- phenylephrine hydrochloride tablet, film coated
- NDC Code(s): 47682-017-33, 47682-017-48, 47682-017-99
- Packager: Unifirst First Aid Corporation
- Category: HUMAN OTC DRUG LABEL
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 March 15, 2022
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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)
