Active Ingredients (In Each Packet)
Acetaminophen 650 mg
Diphenhydramine hydrochloride 25 mg
Phenylephrine hydrochloride 10 mg
Nighttime Severe Cold And Cough Powder, For Solution
FDA Label NDC 68163-541
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuticals Inc for the product Nighttime Severe Cold And Cough (NDC 68163-541). 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 (in each packet), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain reliever / fever reducer
Antihistamine / Cough Suppressant
Nasal Decongestant
Uses
▪ 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
Warnings
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 product▪ skin reddening▪ blisters▪ rash
Allergy alert: acetaminophen may cause severe skin reactions, Symptoms may include:
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
▪ in a child under 12 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 a 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▪ 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▪ taking 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▪ 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.
Directions
▪ do not use more than directed▪ take every 4 hours while symptoms persist, not to exceed 5 packets in 24 hours unless directed by a doctor▪ 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.
Age | Dose |
adults and children 12 years of age and over | one packet |
children under 12 years of age | do not use |
Other Information
▪ each packet contains: potassium 6 mg▪ store at room temperature. Protect from excessive heat and moisture.
Inactive Ingredients
citric acid, FD& C Yellow No. 6, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,
Questions Or Comments?
1-866-467-2748
Principal Display Panels
*Compare to the active ingredients in Theraflu® Nighttime Severe Cold & Cough*
NDC# 68163-541-06
Nighttime
Severe Cold & Cough
ACETAMINOPHEN
PAIN RELIEVER/FEVER REDUER
DIPHENHYDRAMINE HCl
ANTIHISTAMINE/ COUGH SUPPRESSANT
PHENYLEPHRINE HCl
NASAL DECONGESTANT
- Aspartame free
- Sodium Free
- Cough
- Fever
- Headache
- Nasal Congestion
- Runny Nose
- Sneezing
- Sore Throat Pain
Relieves:
Body Ache & Fever
6 PACKETS
Honey Lemon Flavor
Infused with Chamomile & White Tea Flavors
TAMPER EVIDENT: DO NOT USE IF INNER SEALED PACKET IS TORN |
Manufactured by:
Raritan Pharmaceuticals
8 Joanna Court
East Brunswick, NJ 08816
*This product is not manufactured or distributed by GSK consumer Healthcare, owner of the registered trademark THERAFLU® Nighttime Severe Cold & Cough.
* Please review the disclaimer below.
