Maximum Strength Severe Congestion Relief

Maximum Strength Severe Congestion Relief
SPL v5
SPL
SPL Set ID 72233feb-0067-44be-a147-73019fea0235
Route
ORAL
Published
Effective Date 2021-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg) Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitol Sorbitan Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 341 Shape: oval Color: orange Size: 26 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-28

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Uses

• for the temporary relief of the following cold/flu symptoms: • minor aches and pains • headache • sore throat • nasal congestion • cough • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive • temporarily reduces fever

Carton

Section 42229-5

Distributed By:

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779

Made in India

Section 50567-7

When using this product do not exceed recommended dosage

Section 53414-9

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

Directions

do not take more than directed

adults and children 12 years & over • take 2 caplets every 4 hours • swallow whole; do not crush, chew or dissolve • do not take more than 10 caplets in 24 hours
children under 12 years ask a doctor

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. • if you have ever had an allergic reaction to this product or any of its ingredients.

Drug Facts

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.

Liver Warning:

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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

Other Information

store at 25ºC (77ºF); excursions permitted between 15º–30ºC (59º–86ºF)

Inactive Ingredients

FD&C Yellow # 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Sore Throat Warning:

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Questions Or Comments?

1-888-333-9792

Stop Use and Ask A Doctor If

• nervousness, dizziness, or sleeplessness occur • pain, nasal congestion or cough gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Keep Out of Reach of Children.

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.

Active Ingredients (in Each Caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have

• liver disease • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema • cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use

if you are taking the blood thinning drug warfarin


Structured Label Content

Uses

• for the temporary relief of the following cold/flu symptoms: • minor aches and pains • headache • sore throat • nasal congestion • cough • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive • temporarily reduces fever

Carton

Section 42229-5 (42229-5)

Distributed By:

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779

Made in India

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage

Section 53414-9 (53414-9)

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

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Directions

do not take more than directed

adults and children 12 years & over • take 2 caplets every 4 hours • swallow whole; do not crush, chew or dissolve • do not take more than 10 caplets in 24 hours
children under 12 years ask a doctor

Do Not Use (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. • if you have ever had an allergic reaction to this product or any of its ingredients.

Drug Facts

Allergy Alert: (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.

Liver Warning: (Liver warning:)

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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

Other Information (Other information)

store at 25ºC (77ºF); excursions permitted between 15º–30ºC (59º–86ºF)

Inactive Ingredients

FD&C Yellow # 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Sore Throat Warning: (Sore throat warning:)

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• nervousness, dizziness, or sleeplessness occur • pain, nasal congestion or cough gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Keep Out of Reach of Children. (Keep out of reach of children.)

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.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

• liver disease • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema • cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

if you are taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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