FDA Label for Multi Symptom Severe Cold
View Indications, Usage & Precautions
- 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
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY
Multi Symptom Severe Cold Product Label
The following document was submitted to the FDA by the labeler of this product Raritan Pharmaceuticals Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each Packet)
Acetaminophen 500 mg
Dextromethorphan hydrobromide 20 mg
Phenylephrine hydrochloride 10 mg
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 a 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 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▪ 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▪ 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. These 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. do not take more than 6 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, caramel, flavors, maltodextrin ,potassium chloride, silica, sucralose, sucrose,
Questions Or Comments
1-866-467-2748
Principal Display
DRx Choice®
NDC# 68163-547-06
Compare to the active ingredients in Theraflu® Multi-Symptom Severe Cold*
MULTI-SYMPTOM
Severe Cold
ACETAMINOPHEN
PAIN RELIEVER/ FEVER REDUCER
DEXTROMETHORPHAN HBr
COUGH SUPPRESSANT
PHENYLEPHRINE HCl
NASAL DECONGESTANT
• Aspartame Free• Dye free• Sodium free• Body ache• Cough• Fever• Headache• Nasal congestion• Sore throat pain
Relieves
GREEN TEA & HONEY LEMON FLAVORS
Infused with Menthol & Green Tea Flavors
6 PACKETS
TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN.
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® Multi-Symptom Severe Cold.
* Please review the disclaimer below.