Skip to Content

← See all Acetaminophen Dextromethorphan HBr Doxylamine succinate Phenylephrine HCl brands

Acetaminophen Dextromethorphan HBr Doxylamine succinate Phenylephrine HCl

Medically reviewed on July 19, 2017

Dosage form: capsule, liquid filled
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg, ACETAMINOPHEN 325mg, DOXYLAMINE SUCCINATE 6.25mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: CVS PHARMACY,INC
NDC Code: 69842-305

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Severe Non-Drowsy
Sinus Congestion and Cough Relief


Acetaminophen 325 mg each
Dextromethorphan hydrobromide 10 mg each
Phenylephrine hydrochloride 5 mg each

Severe
Sinus Congestion and Cough Relief

Acetaminophen
325 mg each
Dextromethorphan hydrobromide 10 mg each
Doxylamine succinate 6.25 mg each
Phenylephrine hydrochloride 5 mg each

Active ingredients

Severe Sinus Congestion & Cough Relief Day

(in each Softgel)

Acetaminophen325 mg
Dextromethorphan hydrobromide10 mg
Phenylephrine hydrochloride5 mg

Purposes

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Uses

temporarily relieves these symptoms due to cold and flu:

  • sneezing
  • itching of the nose, throat or watery eyes due to hay fever
  • cough
  • nasal congestion
  • sinus congestion and pressure
  • sore throat
  • head ache
  • minor aches and pains

helps clear nasal passages and shrinks swollen membranes

temporarily reduces fever

Warnings

Liver warning

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

Allergy alert

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.

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.

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 ever had an allergic reaction to this product or any of its ingredients.
• in children 12 years of age.

Ask a doctor before use if you have

• 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

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

Stop use and ask a doctor if

• 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

If pregnant or breast-feeding

ask a health professional before use.

Keep out of the reach of children

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.

Directions

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

Other information

• store in a cool and dry place.
• protect from sunlight.
• Parents: Learn about teen medicine abuse, WWW.StopMedicineAbuse.org

Inactive ingredients

FD&C Blue 1, FD&C Red 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan, titanium dioxide

Questions or comments?


call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

Active ingredients

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

Purposes

Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant

Uses

temporarily relieves these symptoms due to cold and flu:

  • sneezing
  • itching of the nose, throat or watery eyes due to hay fever
  • cough
  • nasal congestion
  • sinus congestion and pressure
  • sore throat
  • headache
  • minor aches and pains
  • runny nose

helps clear nasal passages and shrinks swollen membranes
temporarily reduces fever

Warnings

Liver warning

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

Allergy alert

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.

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.

Warnings

Do not use to sedate children

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 ever had an allergic reaction to this product or any of its ingredients.
• in children 12 years of age.

Ask a doctor before use if you have

• 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

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking a blood thinning drug warfarin

When using this product

• 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

Stop use and ask a doctor if

• 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

If pregnant or breast-feeding

ask a health professional before use.

Keep out of the reach of children

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

Directions

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

Other information

• store in a cool and dry place.
• protect from sunlight.
• Parents: Learn about teen medicine abuse, WWW.StopMedicineAbuse.org

Inactive ingredients

FD&C blue 1, FD&C yellow 10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan, titanium dioxide.

Questions or comments?

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCL 
acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-305
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
FD&C RED NO. 40 
WATER 
SODIUM HYDROXIDE 
SORBITAN 
TITANIUM DIOXIDE 
Product Characteristics
Colorgreen (Nighttime) , blue (Daytime) Scoreno score
ShapeOVALSize20mm
FlavorImprint Code314;116
Contains    
Packaging
#Item CodePackage Description
1NDC:69842-305-0220 BLISTER PACK in 1 PACKAGE, COMBINATION
18 BLISTER PACK in 1 BLISTER PACK
112 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/07/2017
Labeler - CVS PHARMACY,INC (062312574)

 
CVS PHARMACY,INC

← See all Acetaminophen Dextromethorphan HBr Doxylamine succinate Phenylephrine HCl brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide