Label: GREEN GUARD ADVANCED SINUS RELIEF- acetaminophen, phenylephrine hydrochloride tablet
- NDC Code(s): 47682-002-33, 47682-002-48, 47682-002-99
- Packager: Unifirst First Aid 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 March 23, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening
■ blisters
■ rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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.
- for more than 10 days unless directed by a doctor
Ask a doctor before use if you have
- liver disease
- thyroid disease
- diabetes
- high blood pressure
- heart disease
- trouble urinating due to an enlarged prostate gland
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
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Green Guard Advanced Sinus Relief Label
Advanced Sinus relief™
Tabletas mejoradas
para el alivio sinusalGREEN GUARD ®
Pull to Open
Tire Para Abrir
Acetaminophen 500mg/Acetaminofeno 500 mg
Phenylephrine HCl 5mg/Fenilefrina HCl 5 mg
Pain Reliever/Fever reducer/ & Nasal Decongestant/ Alivia el dolor y reduce la fiebre y decongestivo nasal
125 Packets of 2 Tablets
250 Tablets
Order #2207
Distributed by Green Guard ®, St Louis, MO 63045 -
INGREDIENTS AND APPEARANCE
GREEN GUARD ADVANCED SINUS RELIEF
acetaminophen, phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color blue (blue) Score no score Shape ROUND (ROUND) Size 12mm Flavor Imprint Code FR33 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-002-33 50 in 1 BOX 12/30/2008 07/01/2024 1 NDC:47682-002-99 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-002-48 125 in 1 BOX 12/30/2008 07/01/2024 2 NDC:47682-002-99 2 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:47682-002-99 2 in 1 PACKET; Type 0: Not a Combination Product 12/30/2008 07/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/30/2008 07/01/2024 Labeler - Unifirst First Aid Corporation (832947092)