FDA Label for Walgreen Daytime Cold And Flu Relief
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS (IN EACH 15 ML)
- PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT:
- SORE THROAT WARNING
- 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
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 354 ML BOTTLE LABEL
Walgreen Daytime Cold And Flu Relief Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens Co.. 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.
Other
Drug Facts
In case of overdose, get medical help or contact a Poison Control Center right away at 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.
*This product is not manufactured or distributed by Procter & Gamble, distributer of Vicks® Dayquil™ Severe Cold & Flu Honey Flavour
Distributed. by:
Active Ingredients (In Each 15 Ml)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifensin 200 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Uses
temporarily relieves common cold/flu symptoms:
• nasal congestion• sinus congestion & pressure• cough due to minor throat & bronchial irritation• minor aches & pains• headache• fever• sore throat• reduces swelling of nasal passages• temporarily restores freer breathing through the nose• promotes nasal and/or sinus drainage• helps loosen phlegm (mucus) and thin bronchial secretions torid the bronchial passageways of bothersome mucus and make coughs more productive.
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if
• adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product• child takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product• taken with other drugs containing acetaminophen• adult has 3 or more alcoholic drinks every day while using this product
Allergy Alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
• Skin reddening• Blisters• Rash
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 is 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.
Ask A Doctor Before Use If You Have
• liver disease• heart disease• high blood pressure• thyroid disease• diabetes• trouble urinating due to enlarged prostate gland• cough that occurs with too much phlegm (mucus)• persists or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
When Using This Product,
do not use more than directed
Stop Use And Ask A Doctor If
• you get nervous, dizzy or sleepless• pain, nasal congestion or cough gets worse or lasts more than 5 days (children) 7 days (adults)• 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
• take only as directed• only use the dose cup provided• do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over 30 mL every 4 hrs
children 6 to under 12 yrs 15 mL every 4 hrs
children 4 to under 6 yrs ask a doctor
children under 4 yrs do not use
Other Information
• each 15 mL contains: sodium 9 mg• Store at room temperature• Do not refrigerate.
Inactive Ingredients
citric acid, D&C Yellow No. 10, edetate disodium, FD&C Green No. 3, FD&C Red No. 40, flavors, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Questions?
1-866-467-2748
Principal Display Panel - 354 Ml Bottle Label
*Compare to the active ingredients in Vicks® Dayquil™ Severe Cold & Flu Honey Flavour
NDC 0363-6110-12
DayTime
Cold & Flu
Relief
Acetaminophen – Pain reliever/Fever reducer
Guaifensin – Expectorant
Phenylephrine HCl - Nasal Congestion
Dextromethorphan HBr – Cough suppressant
• Headache, Fever, Sore Throat, Minor Aches & Pains• Chest Congestion,• Thins & Loosens Mucus• Nasal Congestion, Sinus Pressure• Cough
HONEY FLAVOR
Naturally and Artificially Flavored
12 FL OZ (354 ml)
* Please review the disclaimer below.