SEVERE NIGHTTIME COLD AND FLU
Medically reviewed on December 13, 2017
Dosage form: capsule, gelatin coated
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, DOXYLAMINE SUCCINATE 6.25mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
NDC Code: 0363-0114
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.
|Active ingredients (in each softgel)||Purposes|
|Acetaminophen 325 mg||Pain reliever/fever reducer|
|Dextromethorphan HBr 10 mg||Cough suppressant|
|Doxylamine succinate 6.25 mg||Antihistamine|
|Phenylephrine HCl 5 mg||Nasal decongestant|
temporarily relieves common cold/flu symptoms:
- nasal congestion
- sinus congestion & pressure
- cough due to minor throat & bronchial irritation
- cough to help you sleep
- minor aches & pains
- sore throat
- runny nose & sneezing
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses 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
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.
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
- 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.
- to make a child sleep
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- trouble urinating due to enlarged prostate gland
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
- you get nervous, dizzy or sleepless
- 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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a 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.
- take only as directed - see Overdose warning
- do not exceed 4 doses per 24 hours
|adults & children 12 years & over||2 softgels with water every 4 hours|
|children 4 to under 12 years||ask a doctor|
|children under 4 years||do not use|
- store at room temperature
D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, shellac, sorbitol sorbitan, sodium hydroxide, titanium dioxide
DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015
Call toll free: 1-888-333-9792
Compare to Vicks® NyQuil® Severe
Cold & Flu active ingredients††
Severe Cold & Flu
ACETAMINOPHEN/ PAIN RELIEVER/ FEVER REDUCER
DEXTROMETHORPHAN HBR/ COUGH SUPPRESSANT
DOXYLAMINE SUCCINATE/ ANTIHISTAMINE
PHENYLEPHRINE HCL/ NASAL DECONGESTANT
- Relieves headache, fever, sore throat, minor
aches & pains, nasal/sinus congestion & sinus
pressure, sneezing, runny nose & cough
|SEVERE NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride capsule, gelatin coated
|Labeler - WALGREENS (008965063)|
|Registrant - SPIRIT PHARMACEUTICALS LLC (179621011)|
|MEDGEL PRIVATE LTD||677385498||manufacture(0363-0114)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.