Active Ingredients (In Each Packet)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Severe Cold And Cough Powder, For Solution
FDA Label NDC 68163-540
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 Severe Cold And Cough (NDC 68163-540). 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
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▪ 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 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.
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▪ 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 the blood thinning drug warfarin
When Using This Product
▪ do not exceed recommended dosage
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 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 overdose, get medical help or contact a Poison Control Center right away (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. Do not take more than 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 product from heat and moisture.
Inactive Ingredients
citric acid, FD& C Blue No. 1, FD&C Red No. 40, flavor, maltodextrin, potassium chloride, silica, sucralose, sucrose.
Questions Or Comments?
1-866-467-2748
Package/Label Principal Display Panel
NDC# 68163-540-06
COMPARE TO the active ingredients in Theraflu® Daytime Severe Cold & Cough*
Day Time
Severe Cold & Cough
Acetaminophen
Pain Reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Phenylephrine HCl
Nasal Decongestant
- Aspartame free
- Sodium free
- Body Ache
- Cough
- Fever
- Headache
- Nasal Congestion
- Sore Throat Pain
Relieves
6 PACKETS
BERRY FLAVOR
Infused With Menthol & Green Tea Flavor
TAMPER EVIDENT: DO NOT USE INNER SEALED PACKET IF TORN |
Manufactured by:
Raritan Pharmaceuticals
8 Joanna Court,
East Brunswick, NJ 08816
This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® Daytime Severe Cold & Cough.
Drx Daytime Severe Cold & Cough (Image 01)
* Please review the disclaimer below.
