FDA Label for Severe Cold And Cough Daytime
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH PACKET)
- PURPOSES
- USES
- WARNINGS
- DO NOT USE
- ASK 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
Severe Cold And Cough Daytime Product Label
The following document was submitted to the FDA by the labeler of this product Winco Foods, Llc. 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 Ingredient (In Each Packet)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 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 an MAOI, ask a doctor or pharmacist before taking this product.
Ask 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 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 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, aspartame, FD&C blue # 1, FD&C red # 40, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,
Questions Or Comments?
Call 800-824-1706
Monday-Friday 9am-4pm MST
Principal Display
*Compare to the active ingredients in THERAFLU® Daytime Severe Cold &Cold
WinCo FOODS
Severe Cold & Cough
Daytime
ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUER
DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT
PHENYLEPHRINE HCl – NASAL DECONGESTANT
• Relieves: Nasal Congestion, Sore Throat Pain, Cough, Headache, Body Ache & Fever
6 PACKETS
Berry Infused with Menthol & Green Tea Flavors
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD. |
TAMPER EVIDENT INNER UNIT DO NOT USE IF SEALED PACKET IS TORN OR BROKEN |
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Comments & Questions?
800-824-1706 www.wincofoods.com
DISTRIBUTED BY:
WINCO FOODS, LLC,
BOISE, ID 83704
*This product is not manufactured or distributed by GSK consumer Healthcare, owner of the registered trademark THERAFLU® Daytime Severe Cold & Cough.
* Please review the disclaimer below.