The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Active Ingredients (In Each Packet)
Acetaminophen 650 mgDiphenhydramine hydrochloride 25 mgPhenylephrine hydrochloride 10 mg
Pain reliever / fever reducerAntihistamine / Cough SuppressantNasal Decongestant
- •temporarily relieves these symptoms due to a cold: •minor aches and pains •minor sore throat pain •headache •nasal and sinus congestion •runny nose •sneezing •itchy nose or throat •itchy, watery eyes due to hay fever •cough due to minor throat and bronchial irritation •temporarily reduces fever
- Liver warning: This product contains acetaminophen. 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 productSore 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
- •in a child under 4 years of age •if you are allergic to acetaminophen •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. •with any other product containing diphenhydramine, even one used on the skin •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 a 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 •glaucoma •a sodium-restricted diet •trouble urinating due to an enlarged prostate gland •a breathing problem such as emphysema, asthma or chronic bronchitis •cough that occurs with too much phlegm (mucus) •cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are Taking
- •sedatives or tranquilizers •the blood thinning drug warfarin
When Using This Product
- •do not exceed recommended dosage •avoid alcoholic drinks •marked drowsiness may occur •alcohol, sedatives and tranquilizers may increase drowsiness •be careful when driving a motor vehicle or operating machinery •excitability may occur, especially in children
Stop Use And Ask A Doctor If
- •nervousness, dizziness, or sleeplessness occurs •fever gets worse or lasts more than 3 days •redness or swelling is present •new symptoms occur •symptoms do not get better or worsen •pain, cough or nasal congestion gets worse or lasts more than 7 days •cough comes back or occurs with fever, rash or headache that lasts. There could be signs of a serious condition.
If Pregnant Or Breast- Feeding,
Ask a health care professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- •do not use more than directed •take every 4 hours; not to exceed 5 packets in 24 hours or as directed by a doctorAgeDosechildren under 4 years of agedo not usechildren 4 to under 12 years of agedo not use unless directed by a doctor adults and children 12 years of age and overone packet •dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes. •if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.
- •each packet contains: potassium 6 mg •store at controlled room temperature 20o -25oC (68o-77oF). Protect from excessive heat and moisture.
Citric acid, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose, yellow#6
Additional Information Listed On Other Panels
- LEADERNDC 70000-0128-1Nighttime Severe Cold &CoughAcetaminophenDiphenhydramine HClPhenylephrine HCl Pain reliever/ Fever reducerAntihistamine/ Cough suppressantNasal DecongestantHoney Lemon Infused with Chamomile & White Tea FlavorsNaturally and Artificially FlavoredCOMPARE TO THERAFLU® NIGHTTIME SEVERE COLD & COUGH* active ingredients *100% Money Back GuaranteeRelieves: Nasal Congestion, Cough, Runny Nose, Sneezing, Body Ache, Sore Throat Pain, Headache & Fever6 PACKETSREAD ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE, KEEP CARTON FOR REFERENCE, DO NOT DISCARD,NIGHTTIME Severe Cough & ColdCardinal Health™DISTRIBUTED BY CARDINAL HEALTHDUBLIN, OHIO 43017www.myleader.com1-800-200-6313Essential to care™ since 1979TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN.©2017 CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu® Nighttime Severe Cold & Cough.
* Please review the disclaimer below.