Day time cold and fluenon drowsynon drowsy capsule, liquid filled
Active ingredient (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg
Pain reliever/fever reducer
temporarily relieves common cold and flu symptoms: nasal congestion cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever
Liver warning: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
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.
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 products 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 Parkinsons disease), or for 2 weeks after stopping the MAOI drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
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, 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
When using this product
do not exceed recommended dosage
Stop use and ask a doctor if
you get nervous, dizzy or sleepless symptoms get worse or lasts more than 5 days(children) or 7 days (adults) 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.
In case of accidental overdose, contact a doctor or Poison Control Center immediately (1-800-222-1222). Taking more than the recommended dose (overdose) may cause liver damage. 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 directed (see
do not exceed 4 doses per 24 hours
Adults and children 12 years and over:take 2 softgels every 4 hours
Children 4 to under 12 years:ask a doctor
Children under 4 years: do not use this
store at room temperature do not use if blister is torn or open
FD&C Red #40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol. May also contain FD&C Yellow #6, titanium dioxide
Questions or comments?
Call toll free 1-888-952-0050
Ingredients and appearance - Product information
Day time cold and fluenon drowsynon drowsy capsule, liquid filled- Acetaminophen 325 mg, dextromethorphan hbr 10 mg, phenylephrine hci 5 mg
|Product Type||HUMAN OTC DRUG LABEL||Item Code (Source)||NDC: 69168-356|
|Route of Administration||Oral|
|Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D )||325 mgin 1|
|Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS )||10 mgin 1|
|Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV )||5 mgin 1|
|Fd&c red no. 40||( UNII: WZB9127XOA)|
|Gelatin||( UNII: 2G86QN327L)|
|Glycerin||( UNII: PDC6A3C0OX)|
|Polyethylene glycol 400||( UNII: B697894SGQ)|
|Povidone||( UNII: FZ989GH94E)|
|Polyethylene glycol, unspecified||( UNII: 3WJQ0SDW1A)|
|Water||( UNII: 059QF0KO0R)|
|Sorbitol||( UNII: 506T60A25R)|
|#||Item Code||Package Description||Marketing Start Date|
|1||NDC: 69168-356-29||8 in 1 BOX||2015/03/03|
|2||NDC: 69168-356-51||20 in 1 BOX||2015/03/03|
|Marketing Category||Application Number or Monograph Citation||Territorial Authority||Marketing Start Date|
|OTC MONOGRAPH FINAL||part341||USA||2015/03/03|
Labeler - Allegiant Health( 079501930)
Package/label principal display panel