FDA Label for Severe Cough And 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?
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Severe Cough And Cold Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
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 have ever had an allergic reaction to this product or any of its ingredients• 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 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 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• glaucoma• trouble urinating due to an enlarged prostate gland• a breathing problem such as emphysema 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 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.
Overdose warning: 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 (see overdose warning)• 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 10 mg and sodium 25 mg• phenylketonurics: contains phenylalanine 13 mg per packet• store at 20-25°C (68-77°F). Protect product from heat and moisture.
Inactive Ingredients
acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate
Questions Or Comments?
1-800-719-9260
Package/Label Principal Display Panel
Compare to the active ingredients in Theraflu® Nighttime Severe Cold & Cough
Severe
NIGHTTIME
Severe Cough & Cold
ACETAMINOPHEN
Pain reliever; Fever reducer
DIPHENHYDRAMINE HCl
Antihistamine; Cough suppressant
PHENYLEPHRINE HCl
Nasal decongestant
Relieves:
Nasal congestion
Cough
Runny nose
Sneezing
Body ache
Sore throat pain
Headache / fever
Honey Lemon inflused with White Tea Flavors
6 PACKETS
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