NDC | 47682-001-33, 47682-001-48, 47682-001-99 |
Set ID | e8e5fb21-a7fd-44d1-b9c4-83e949699ca6 |
Category | HUMAN OTC DRUG LABEL |
Packager | Unifirst First Aid Corporation |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Purpose
- INDICATIONS & USAGE
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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
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
When using this product do not exceed recommended dosage.
- 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 500mg
Phenylephrine HCl 5mg/Fenilefrina HCl 5mg
Pain Reliever & Fever Reducer & Nasal Decongestant / Alivia el dolor y reduce la fiebre y descongestivo 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:47682-001 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) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) CROSPOVIDONE (UNII: 68401960MK) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) Product Characteristics Color white (white) Score no score Shape ROUND (ROUND) Size 12mm Flavor Imprint Code AZ;261 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-001-33 50 in 1 BOX 12/30/2008 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:47682-001-48 125 in 1 BOX 12/30/2008 2 NDC:47682-001-99 2 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:47682-001-99 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(47682-001) , repack(47682-001)