Maximum Strength Severe Congestion Relief
72233feb-0067-44be-a147-73019fea0235
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:04:49.024424 · Updated: 2026-03-14T23:05:48.377821