819r Green Guard Advanced Sinus Relief

SPL v15

SPL

SPL Set ID e8e5fb21-a7fd-44d1-b9c4-83e949699ca6

Route

ORAL

Published

Effective Date 2023-03-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Phenylephrine (5 mg)

Inactive Ingredients

Cellulose, Microcrystalline Hypromelloses Polyethylene Glycol, Unspecified Starch, Corn Stearic Acid Crospovidone Povidone, Unspecified

Identifiers & Packaging

Pill Appearance

Imprint: AZ;261 Shape: round Color: white Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2008-12-30

Description

Drug Facts

Medication Information

Warnings and Precautions

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.

Indications and Usage

Uses

temporarily relieves these common cold/flu symptoms:

nasal congestion
headache
minor aches and pains
stuffy nose
sinus congestion and pressure

temporarily reduces fever

Dosage and Administration

Directions

■ do not use more than directed

Adults and children: (12 years and over) Take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Overdose warning:

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

you get nervous, dizzy, or sleepless
pain or nasal congestion gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms appear

These could be signs of a serious condition.

Section 50567-7

When using this product do not exceed recommended dosage.

Section 50568-5

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Section 50569-3

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

Section 50570-1

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

Section 51727-6

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid.

Section 51945-4

Advanced Sinus relief™

Acetaminophen 500mg/Acetaminofeno 500mg

Phenylephrine HCl 5mg/Fenilefrina HCl 5mg

Tabletas mejoradas para el alivio sinusal

Pain Reliever & Fever Reducer & Nasal Decongestant / Alivia el dolor y reduce la fiebre y descongestivo nasal

Pull to Open

Tire Para Abrir

GREEN GUARD ®

50 Packets of 2 Tablets

100 Tablets

Order #2206

Distributed by Green Guard ®, St Louis, MO 63045

Section 53413-1

Questions or comments? 1-800-869-6970

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Pain reliever/fever reducer

Nasal decongestant

Section 55106-9

Active ingredients (in each tablet)

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

Section 60561-8

Other information

store at room temperature 59º-86ºF (15º-30ºC)
tamper evident sealed packets
do not use any opened or torn packets
avoid excessive heat and humidity

Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves these common cold/flu symptoms:

nasal congestion
headache
minor aches and pains
stuffy nose
sinus congestion and pressure

temporarily reduces fever

Dosage and Administration (34068-7)

Directions

■ do not use more than directed

Adults and children: (12 years and over) Take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Ask a doctor

Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning:

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

you get nervous, dizzy, or sleepless
pain or nasal congestion gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms appear

These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid.

Section 51945-4 (51945-4)

Advanced Sinus relief™

Acetaminophen 500mg/Acetaminofeno 500mg

Phenylephrine HCl 5mg/Fenilefrina HCl 5mg

Tabletas mejoradas para el alivio sinusal

Pain Reliever & Fever Reducer & Nasal Decongestant / Alivia el dolor y reduce la fiebre y descongestivo nasal

Pull to Open

Tire Para Abrir

GREEN GUARD ®

50 Packets of 2 Tablets

100 Tablets

Order #2206

Distributed by Green Guard ®, St Louis, MO 63045

Section 53413-1 (53413-1)

Questions or comments? 1-800-869-6970

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

Section 60561-8 (60561-8)

Other information

store at room temperature 59º-86ºF (15º-30ºC)
tamper evident sealed packets
do not use any opened or torn packets
avoid excessive heat and humidity

Advanced Ingredient Data

[{"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE", "unii": "68401960MK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses temporarily relieves these common cold/flu symptoms: nasal congestion headache minor aches and pains stuffy nose sinus congestion and pressure temporarily reduces fever", "34068-7": "Directions ■ do not use more than directed Adults and children: (12 years and over) Take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours. Children under 12 years: Ask a doctor", "34071-1": "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.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "50566-9": "Stop use and ask a doctor if you get nervous, dizzy, or sleepless pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms appear These could be signs of a serious condition.", "50567-7": "When using this product do not exceed recommended dosage.", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin", "50569-3": "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", "50570-1": "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", "51727-6": "Inactive ingredients corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid.", "51945-4": "Advanced Sinus relief™ Acetaminophen 500mg/Acetaminofeno 500mg Phenylephrine HCl 5mg/Fenilefrina HCl 5mg Tabletas mejoradas para el alivio sinusal Pain Reliever & Fever Reducer & Nasal Decongestant / Alivia el dolor y reduce la fiebre y descongestivo nasal Pull to Open Tire Para Abrir GREEN GUARD ® 50 Packets of 2 Tablets 100 Tablets Order #2206 Distributed by Green Guard ®, St Louis, MO 63045", "53413-1": "Questions or comments? 1-800-869-6970", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Pain reliever/fever reducer Nasal decongestant", "55106-9": "Active ingredients (in each tablet) Acetaminophen 500 mg Phenylephrine HCl 5 mg", "60561-8": "Other information store at room temperature 59º-86ºF (15º-30ºC) tamper evident sealed packets do not use any opened or torn packets avoid excessive heat and humidity"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:57.473699 · Updated: 2026-03-14T23:10:05.459246