The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy,inc for the product Acetaminophen Dextromethorphan Hbr Doxylamine Succinate Phenylephrine Hcl (NDC 69842-305). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purposes, uses, liver warning, allergy alert, sore throat warning, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Severe Sinus Congestion & Cough Relief Day
(in each Softgel)
| Acetaminophen | 325 mg |
| Dextromethorphan hydrobromide | 10 mg |
| Phenylephrine hydrochloride | 5 mg |
Severe Sinus Congestion & Cough Relief Night
(in each Softgel)
| Acetaminophen | 325 mg |
| Dextromethorphan hydrobromide | 10 mg |
| Doxylamine succinate | 6.25 mg |
| Phenylephrine hydrochloride | 5 mg |
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
temporarily relieves these symptoms due to cold and flu:
helps clear nasal passages and shrinks swollen membranes
temporarily reduces fever
temporarily relieves these symptoms due to cold and flu:
helps clear nasal passages and shrinks swollen membranes
temporarily reduces fever
This product contains acetaminophen. Severe liver damage may occur if you take
• more than 10 softgels in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
This product contains acetaminophen. Severe liver damage may occur if you take
• more than 10 softgels in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
• skin reddening
• blisters
• rash
• hives
• facial swelling
• asthma (wheezing)
• shock
If a skin or allergic reaction occurs, stop use and seek medical help right away.
acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
• skin reddening
• blisters
• rash
• hives
• facial swelling
• asthma (wheezing)
• shock
If a skin or allergic reaction occurs, stop use and seek medical help right away.
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.
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.
• 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 ever had an allergic reaction to this product or any of its ingredients.
• in children 12 years of age.
• 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 ever had an allergic reaction to this product or any of its ingredients.
• in children 12 years of age.
• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• cough with excess phlegm (mucus)
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough occurs with smoking, asthma, or emphysema
• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• cough with excess phlegm (mucus)
• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough occurs with smoking, asthma, or emphysema
taking the blood thinning drug warfarin
• taking sedatives or tranquilizers
• taking a blood thinning drug warfarin
do not exceed recommended dosage
• do not exceed recommended dose
• may cause marked drowsiness
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving motor vehicles or operating machinery
• may cause excitability in children
• pain, cough, 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 occur
• cough comes back or occurs with rash or head ache that lasts for 1 week, these could be the signs of serious condition
• nervousness, dizziness, or sleeplessness occurs
• pain, cough, 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 occur
• cough comes back or occurs with rash or head ache that lasts for 1 week, these could be the signs of serious condition
• nervousness, dizziness, or sleeplessness occurs
ask a health professional before use.
ask a health professional before use.
In case of overdose, get medical help or contact Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
In case of overdose, get medical help or contact Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Do not take more than the recommended dose
adults & children under 12 years and over
- take 2 softgels with water every 4 hours.
- do not exceed 10 softgels in 24 hours or as directed by a doctor
children under 12 years
- do not use
Do not take more than the recommended dose
adults & children under 12 years and over
- take 2 softgels with water every 4 hours.
- do not exceed 10 softgels in 24 hours or as directed by a doctor
children under 12 years
- do not use
• store in a cool and dry place.
• protect from sunlight.
• Parents: Learn about teen medicine abuse, WWW.StopMedicineAbuse.org
• store in a cool and dry place.
• protect from sunlight.
• Parents: Learn about teen medicine abuse, WWW.StopMedicineAbuse.org
FD&C Blue 1, FD&C Red 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan, titanium dioxide
FD&C blue 1, FD&C yellow 10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan, titanium dioxide.
call
1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST
call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST
Do not use to sedate children
20 Count (968340 Lr1)
* Please review the disclaimer below.
