FDA Label for Equate Vapor Ice Cold And Flu
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH CAPLET)
- PURPOSE
- 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
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Equate Vapor Ice Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Wal-mart Stores 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 Caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Uses
• temporarily relieves common cold/flu symptoms:• nasal congestion• sinus congestion and pressure• cough due to minor throat and bronchial irritation• cough to help you sleep• minor aches and pains• headache• fever• sore throat• runny nose and sneezing• reduces swelling of nasal passages• temporarily restores freer breathing through the nose• promotes nasal and/or sinus drainage
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
• 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.• if you have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If You Have
• liver disease• heart disease• high blood pressure• thyroid disease• diabetes• glaucoma• cough that occurs with too much phlegm (mucus)• a breathing problem such as emphysema or chronic bronchitis• persistent or chronic cough such as occurs with smoking, asthma, or emphysema• trouble urinating due to an enlarged prostate gland
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 use more than directed• excitability may occur, especially in children• marked drowsiness may occur• avoid alcoholic drinks• be careful when driving a motor vehicle or operating machinery• alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
• you get nervous, dizzy or sleepless• pain, nasal congestion, or cough gets worse or lasts more than 7 days• fever gets worse or lasts more than 3 days• redness or swelling is present• new symptoms occur• 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). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
• take only as directed – see overdose warning• do not exceed 8 caplets per 24 hrs
adults & children 12 yrs & over | 2 caplets with water every 4 hrs |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
Inactive Ingredients
crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide
Questions Or Comments?
1-888-287-1915
Package/Label Principal Display Panel
Compare to Vicks® NyQuil® Severe+ VapoCOOL™ active ingredients
SEVERE+
NIGHTTIME
VAPOR ICE™ Cold & Flu
Acetaminophen – Pain Reliever/Fever Reducer
Phenylephrine HCl – Nasal Decongestant
Doxylamine Succinate – Antihistamine
Dextromethorphan HBr – Cough Suppressant
Relief of:
Minor aches & pains, fever
Nasal congestion & sinus pressure
Sneezing, runny nose
Cough
Alcohol-Free
Actual Size
24 CAPLETS
* Please review the disclaimer below.